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Injection of buprenorphine and buprenorphine/naloxone tablets in Malaysia

Vicknasingam B, Mazlan M, Schottenfeld RS, Chawarski MC

Drug Alcohol Depend, 2010 Sep 1;111(1-2):44-9.
PMID: 20478668 DOI: 10.1016/j.drugalcdep.2010.03.014

Buprenorphine maintenance is efficacious for treating opioid dependence, but problems with diversion and misuse of buprenorphine (BUP) may limit its acceptability and dissemination. The buprenorphine/naloxone combination tablet (BNX) was developed to reduce potential problems with diversion and abuse. This paper provides data regarding the characteristics of BUP injection drug users in Malaysia and preliminary data regarding the impact of withdrawing BUP and introducing BNX. BUP was introduced in 2002 and subsequently withdrawn from the Malaysian market in 2006. BNX was introduced in 2007.
Fulltext Maintenance treatment with buprenorphine and naltrexone for heroin dependence in Malaysia: a randomised, double-blind, placebo-controlled trial

Schottenfeld RS, Chawarski MC, Mazlan M

Lancet, 2008 Jun 28;371(9631):2192-200.
PMID: 18586174 DOI: 10.1016/S0140-6736(08)60954-X

Expansion of access to effective treatments for heroin dependence is a worldwide health priority that will also reduce HIV transmission. We compared the efficacy of naltrexone, buprenorphine, and no additional treatment, in patients receiving detoxification and subsequent drug counselling, for maintenance of heroin abstinence, prevention of relapse, and reduction of HIV risk behaviours.
Behavioral drug and HIV risk reduction counseling (BDRC) with abstinence-contingent take-home buprenorphine: a pilot randomized clinical trial

Chawarski MC, Mazlan M, Schottenfeld RS

Drug Alcohol Depend, 2008 Apr 1;94(1-3):281-4.
PMID: 18164145 DOI: 10.1016/j.drugalcdep.2007.11.008

This pilot randomized clinical trial evaluated whether the efficacy of office-based buprenorphine maintenance treatment (BMT), provided with limited counseling or oversight of medication adherence is improved by the addition of individual drug counseling and abstinence-contingent take-home doses of buprenorphine. After a 2-week buprenorphine and stabilization period, heroin dependent individuals (n=24) in Muar, Malaysia were randomly assigned to Standard Services BMT (physician administered advice and support, and weekly, non-contingent medication pick-up) or Enhanced Services (nurse-delivered manual-guided behavioral drug and HIV risk reduction counseling (BDRC) and abstinence-contingent take-home buprenorphine (ACB), 7 day supply maximum). Outcomes included retention, proportion of opioid-negative urine tests, self-reported drug use, and self-reported HIV risk behaviors. 12/12 (100%) of Enhanced Services and 11/12 (92%) of Standard Services participants completed the entire protocol. The proportion of opioid-negative urine tests increased significantly over time for both groups (p<0.001), and the reductions were significantly greater in the Enhanced Services group (p<0.05); Enhanced Services group achieved higher overall proportions of opiate negative urine toxicology tests (87% vs. 69%, p=0.04) and longer periods of consecutive abstinence from opiates (10.3 weeks vs. 7.8 weeks, p=0.154). Both groups significantly reduced HIV risk behaviors during treatment (p<0.05), but the difference between Enhanced and Standard Services (26% vs. 17% reductions from the baseline levels, respectively) was not statistically significant (p=0.9). Manual-guided behavioral drug and HIV risk reduction counseling and abstinence-contingent take-home buprenorphine appear promising for adding to the efficacy of office-based BMT provided with limited drug counseling and medication oversight.
Heroin dependence and HIV infection in Malaysia

Chawarski MC, Mazlan M, Schottenfeld RS

Drug Alcohol Depend, 2006 Apr;82 Suppl 1:S39-42.
PMID: 16769444

BACKGROUND: Malaysia is experiencing severe problems with heroin dependence and HIV infection. This, study evaluated drug use and other HIV risk behaviors and their association with HIV and other infectious diseases in heroin-dependent subjects enrolled in a clinical trial of drug abuse treatment in Muar, Malaysia.
METHODS: Baseline assessment of treatment-seeking subjects (n=177) included the Addiction Severity Index; AIDS Risk Inventory; serological tests for HIV, hepatitis B, and hepatitis C; and chest X-ray.
RESULTS: All of the subjects were male; 67.8% were Malays, 28.8% Chinese, and 2.3%. Indian. Subjects had a mean (SD) age of 37.2 (9.1) years and 14.4 (8.5) years of using heroin; 76.3% reported lifetime injection drug use (IDU), and 41.5% reported current IDU; 30 of 156 (19.2%) tested HIV positive, 143 of 159 (89.9%) tested hepatitis C positive, and 25 of 159 (15.7%) had radiological evidence of pulmonary tuberbulosis. Malay subjects had a significantly higher prevalence of current IDU, needle sharing (p<0.01), and HIV infection (p<0.05) compared with Chinese subjects. Lifetime IDU, needle sharing, lack of consistent condom use, and Malay ethnicity were significantly associated with HIV infection.
CONCLUSIONS: The high prevalence of HIV infection among heroin-dependent individuals, in Malaysia supports the important of interventions to reduce the major risk factors for HIV, including IDU, needle sharing, and unprotected sex.
New challenges and opportunities in managing substance abuse in Malaysia

Mazlan M, Schottenfeld RS, Chawarski MC

Drug Alcohol Rev, 2006 Sep;25(5):473-8.
PMID: 16939945

Until recently, Malaysia has lagged behind in the treatment of drug addiction and related disorders, despite experiencing severe drug problems. By the end of 2004, 234,000 heroin users or heroin-dependent individuals had been registered in the official government registry, but other estimates exceed 500,000 for heroin abusers in the country. Amphetamine-type stimulant abuse is also increasing and of considerable public and government concern. Among the population of drug users, HIV and other infectious diseases rates are very high. In the Western Pacific regions, Malaysia has the second highest HIV prevalence (after Vietnam) among adult populations (0.62%) and the highest proportion of HIV cases resulting from injection drug use (76.3%). Drug use and related disorders exert a heavy burden on the country's health care and legal systems. Historically, drug abusers were rehabilitated involuntarily in correctional, rather than health-care, facilities. This primarily criminal treatment approach had limited effectiveness which led to widespread public dissatisfaction and the recent introduction of medical treatments for addiction. Naltrexone was introduced in 1999; buprenorphine was introduced in 2001 and methadone in 2003. Agonist maintenance programmes were embraced rapidly by the medical community in Malaysia. Currently, over 30,000 opiate-dependent patients are treated with agonist maintenance treatments by more than 500 medical practitioners in Malaysia. Despite these recent advances, treatments for amphetamine-type stimulant abuse or dependence are underdeveloped, and diversion of agonist medications is an emerging concern.
Behavioral counseling and abstinence-contingent take-home buprenorphine in general practitioners' offices in Malaysia: a randomized, open-label clinical trial

Schottenfeld RS, Chawarski MC, Mazlan M

Addiction, 2021 08;116(8):2135-2149.
PMID: 33404150 DOI: 10.1111/add.15399

BACKGROUND AND AIM: To address the widespread severe problems with opioid use disorder, buprenorphine-naloxone treatment provided by primary care physicians has greatly expanded treatment access; however, treatment is often provided with minimal or no behavioral interventions. Whether or which behavioral interventions are feasible to implement in various settings and improve treatment outcomes has not been established. This study aimed to evaluate two behavioral interventions to improve buprenorphine-naloxone treatment.
DESIGN: A 2 × 2 factorial, repeated-measures, open-label, randomized clinical trial.
SETTINGS: General medical practice offices in Muar, Malaysia.
PARTICIPANTS: Opioid-dependent individuals (n = 234).
INTERVENTIONS: Participants were randomly assigned to one of four treatment conditions and received study interventions for 24 weeks: (1) physician management with or without behavioral counseling and (2) physician management with or without abstinence-contingent buprenorphine-naloxone (ACB) take-home doses.
MEASUREMENTS: The primary outcomes were proportions of opioid-negative urine tests and HIV risk behaviors [assessed by audio computer-assisted AIDS risk inventory (ACASI-ARI)].
FINDINGS: The rates of opioid-negative urine tests over 24 weeks of treatment were significantly higher with [68.2%, 95% confidence interval (CI) = 65-71] than without behavioral counseling (59.2%, 95% CI = 56-62, P
Fulltext Lifetime ATS use and increased HIV risk among not-in-treatment opiate injectors in Malaysia

Chawarski MC, Vicknasingam B, Mazlan M, Schottenfeld RS

Drug Alcohol Depend, 2012 Jul 1;124(1-2):177-80.
PMID: 22266088 DOI: 10.1016/j.drugalcdep.2011.12.024

Malaysia has been experiencing significant drug abuse problems since the 1970s, and drug abuse is the major driver of HIV transmission in Malaysia. We investigated risk factors for HIV associated with use of amphetamine type stimulants (ATS) among not-in-treatment opiate injectors in Malaysia.
Buprenorphine/naloxone treatment practices in Malaysia: Results of national surveys of physicians and patients

Vicknasingam B, Dazali MN, Singh D, Schottenfeld RS, Chawarski MC

Drug Alcohol Depend, 2015 Jul 1;152:164-9.
PMID: 25935736 DOI: 10.1016/j.drugalcdep.2015.04.007

Medication assisted treatment with buprenorphine/naloxone (Bup/Nx), including prescribing and dispensing practices of general practitioners (GPs) in Malaysia and their patients' experiences with this treatment have not been systematically examined. The current study surveyed GPs providing Bup/Nx treatment and patients receiving office-based Bup/Nx treatment in Malaysia.
Fulltext Substance abuse and the HIV situation in Malaysia

Singh D, Chawarski MC, Schottenfeld R, Vicknasingam B

J Food Drug Anal, 2013 Dec;21(4):S46-S51.
PMID: 25278737 DOI: 10.1016/j.jfda.2013.09.033

Heroin continues to be the main drug used in Malaysia, while amphetamine-type stimulants (ATS) have been recently identified as a growing problem. A cumulative total of 300,241 drug users were detected between 1988 and 2006. It is also estimated that Malaysia has 170,000 injecting drug users. HIV prevalence among drug users in the country ranges from 25% to 45%. Currently, there are approximately 380 general medical practice offices that offer agonist maintenance treatments for approximately 10,000 patients. There are 27,756 active patients in 333 general medical practice offices and government-run methadone maintenance treatment (MMT) centers. The Needle Syringe Exchange Program (NSEP) reached out to 34,244 injection drug users (IDUs) in 2011. In the last 2 years (2011 and 2012) the number of detected drug addicts decreased from 11,194 to 9015. The arrests made by the police related to opiate and cannabis use increased from 41,363 to 63,466 between the years 2008 and 2010, but decreased since 2010. An almost four-fold increase in the number of ATS and ketamine users was detected from 2006 (21,653 users) 2012 (76,812). Between 2004 and 2010, the yearly seizures for heroin ranged between 156 to 270 kg. However, in 2010 and 2011, heroin seizures showed a significant increase of 445kg and 410.02 kg, respectively. There has been a seizure of between 600 to 1000kg of syabu yearly from 2009 to 2012. Similar to heroin, increased seizures for Yaba have also been observed over the last 2 years. A significant increase has also been recorded for the seizures of ecstasy pills from 2011 (47,761 pills) to 2012 (634,573 pills). The cumulative number of reported HIV infections since 1986 is 94,841. In 2011, sexual activity superseded injection drug use as the main transmission factor for the epidemic. HIV in the country mainly involves males, as they constitute 90% of cumulative HIV cases and a majority of those individuals are IDUs. However, HIV infection trends are shifting from males to females. There are 37,306 people living with HIV (PLHIV) who are eligible for treatment, and 14,002 PLHIV were receiving antiretroviral treatment (ART) in 2011. The decreasing trend of heroin users who have been detected and arrested could be due to the introduction of medical treatments and harm reduction approaches for drug users, resulting in fewer drug users being arrested. However, we are unable to say with certainty why there has been an increase in heroin seizures in the country. There has been an increasing trend in both ATS users and seizures. A new trend of co-occurring opiate dependence and ATS underscores the need to develop and implement effective treatments for ATS, co-occurring opiate and ATS, and polysubstance abuse disorders. The low numbers of NSEP clients being tested for HIV underscores our caution in interpreting the decline of HIV infections among drug users and the importance of focusing on providing education, prevention, treatment, and outreach to those who are not in treatment.
Fulltext COVID-19 Impact on Healthcare and Supportive Services for People Who Use Drugs (PWUDs) in Malaysia

Vicknasingam B, Mohd Salleh NA, Chooi WT, Singh D, Mohd Zaharim N, Kamarulzaman A, et al.

Front Psychiatry, 2021;12:630730.
PMID: 33854449 DOI: 10.3389/fpsyt.2021.630730

Background: Restrictive orders and temporary programmatic or ad hoc changes within healthcare and other supportive systems that were implemented in response to the COVID-19 epidemic in Malaysia may have created hindrances to accessing healthcare and/or receiving other supportive services for people who use drugs (PWUDs). Design: A primarily qualitative study has been conducted to evaluate how service providers and recipients were adapting and coping during the initial periods of the COVID-19 response. Settings: The study engaged several healthcare and non-governmental organizations (NGOs) in the peninsular states of Penang, Kelantan, Selangor, and Melaka. Participants: Medical personnel of methadone maintenance treatment (MMT) programs (n = 2) and HIV clinics (n = 3), staff of NGO services (n = 4), and MMT patients (n = 9) were interviewed using a semi-structured format. Results: Interviewed participants reported significant organizational, programmatic, and treatment protocols related changes implemented within the healthcare and support services in addition to nationally imposed Movement Control Orders (MCOs). Changes aimed to reduce patient flow and concentration at the on-site services locations, including less frequent in-person visits, increased use of telemedicine resources, and greater reliance on telecommunication methods to maintain contacts with patients and clients; changes in medication dispensing protocols, including increased take-home doses and relaxed rules for obtaining them, or delivery of medications to patients' homes or locations near their homes were reported by the majority of study participants. No significant rates of COVID-19 infections among PWUDs, including among those with HIV have been reported at the study sites. Conclusions: Although the reported changes presented new challenges for both services providers and recipients and resulted in some degree of initial disruption, generally, all participants reported successful implementation and high levels of compliance with the newly introduced restrictions, regulations, and protocols, resulting in relatively low rates of treatment disruption or discontinuation at the study sites.
Legal challenges in providing treatment for people who use drugs (PWUDs) in Malaysia

Vicknasingam B, Mohd Salleh NA, Ramadah R, Singh D, Kamarulzaman A, Chawarski MC

Int J Drug Policy, 2021 11;97:103311.
PMID: 34111680 DOI: 10.1016/j.drugpo.2021.103311
Analgesic effects of main indole alkaloid of kratom, mitragynine in acute pain animal model

Mat NH, Bakar SNS, Murugaiyah V, Chawarski MC, Hassan Z

Behav Brain Res, 2023 Feb 15;439:114251.
PMID: 36503042 DOI: 10.1016/j.bbr.2022.114251

Mitragynine exerts its analgesic effect mainly via opioid receptors activation. Additionally, the effect may be mediated via mitragynine's anti-inflammatory property and non-opioid receptor pain pathways, namely through the TRPV1 receptor. No studies identify hitherto, hence, the current study aimed to investigate the mitragynine's analgesic effect via the anti-inflammatory property, non-opioid receptor (TRPV1) and the effective dose (ED) to alleviate pain. Male and female Sprague Dawley rats were pre-treated intraperitoneally with either mitragynine (1, 5, 10, 13, 15 or 30 mg/kg), vehicle, or indomethacin (1 mg/kg) 30 min before inducing inflammatory pain using acetic acid. The writhes and pain-related withdrawal behaviour occurrence were counted within a 1-h duration. Percentage of writhes inhibition, pain-related withdrawal behaviour aggregate, ED50 and ED95 were determined. The body temperature was recorded and TRPV1 expression in the rats' brains was measured. Mitragynine (except 1 mg/kg) significantly reduced the number of writhes compared with the vehicle administered group. Mitragynine (30 mg/kg) demonstrated 99.5% inhibition of writhing behaviour and low withdrawal behaviour score compared with vehicle and indomethacin and successfully blocked the hypothermia induced by acetic acid. The overall ED50 and ED95 values of mitragynine were 3.62 and 20.84 mg/kg, respectively. The percentage of writhing inhibition and withdrawal behaviour were similar in both genders. Mitragynine (15 and 30 mg/kg) significantly reduced the TRPV1 expression in the brain of the rats. Mitragynine alleviated pain-like behaviour and showed analgesic effects via anti-inflammatory and non-opioid receptor pathways. The findings also suggest that mitragynine might regulate some physiological functions of the rat.
Emerging Drug Use Trends in Kelantan, Malaysia

Desrosiers A, Chooi WT, Zaharim NM, Ahmad I, Mohd Yasin MA, Syed Jaapar SZ, et al.

J Psychoactive Drugs, 2016 05 25;48(3):218-26.
PMID: 27224011 DOI: 10.1080/02791072.2016.1185553

The primarily rural and agrarian Kelantan province of Malaysia has high rates of drug use and is characterized by unique sociocultural factors. Combining qualitative and ethnographic methods, we investigated drug use and treatment needs of people who use drugs (PWUD) in rural areas of Kelantan. In February 2014, field visits, participant observation, and focus group discussions (FGDs) with 27 active PWUD were conducted in rural areas surrounding the capital city of Kelantan. The findings indicate a high prevalence of opiate and amphetamine type stimulants (ATS) use in these areas. FGD participants reported initiating drug use at early ages due to peer influences, to relieve boredom, to cope with problems, and a high saturation of villages with other PWUD was reported as a major contributor to their own continued drug use. They reported a trend of drug use initiation at younger ages and increased drug use among females. Participants were interested in treatment; however, their limited knowledge about treatment options and perceived limited availability of services were barriers to treatment seeking. Easy access to drugs, primarily from Thailand and facilitated by the use of mobile phones, resulted in an expanding prevalence of drug use that underscores the need to bolster education and prevention efforts and accessibility of treatment services in Kelantan.
Fulltext Early Initiation of Amphetamine-Type Stimulants (ATS) Use Associated with Lowered Cognitive Performance among Individuals with Co-Occurring Opioid and ATS Use Disorders in Malaysia

Chooi WT, Mohd Zaharim N, Desrosiers A, Ahmad I, Yasin MAM, Syed Jaapar SZ, et al.

J Psychoactive Drugs, 2017 06 29;49(4):326-332.
PMID: 28661714 DOI: 10.1080/02791072.2017.1342152

Amphetamine-type stimulants (ATS) use is increasingly prevalent in Malaysia, including among individuals who also use opioids. We evaluated cognitive functioning profiles among individuals with co-occurring opioid and ATS dependence and their lifetime patterns of drug use. Participants (N = 50) enrolling in a clinical trial of buprenorphine/naloxone treatment with or without atomoxetine completed the Raven's Standard Progressive Matrices, Rey-Osterrieth Complex Figure Test, Digit Span, Trail Making and Symbol Digit Substitution tasks. Multidimensional scaling and a K-means cluster analyses were conducted to classify participants into lower versus higher cognitive performance groups. Subsequently, analyses of variance procedures were conducted to evaluate between group differences on drug use history and demographics. Two clusters of individuals with distinct profiles of cognitive performance were identified. The age of ATS use initiation, controlling for the overall duration of drug use, was significantly earlier in the lower than in the higher cognitive performance cluster: 20.9 (95% CI: 18.0-23.8) versus 25.2 (95% CI: 22.4-28.0, p = 0.038). While adverse effects of ATS use on cognitive functioning can be particularly pronounced with younger age, potentially related to greater vulnerability of the developing brain to stimulant and/or neurotoxic effects of these drugs, the current study findings cannot preclude lowered cognitive performance before initiation of ATS use.
Fulltext Atomoxetine for amphetamine-type stimulant dependence during buprenorphine treatment: A randomized controlled trial

Schottenfeld RS, Chawarski MC, Sofuoglu M, Chooi WT, Zaharim NM, M Yasin MA, et al.

Drug Alcohol Depend, 2018 05 01;186:130-137.
PMID: 29573648 DOI: 10.1016/j.drugalcdep.2018.01.017

BACKGROUND: Amphetamine type stimulants (ATS) use is highly prevalent and frequently co-occurs with opioid dependence in Malaysia and Asian countries. No medications have established efficacy for treating ATS use disorder. This study evaluated the safety, tolerability, and potential efficacy of atomoxetine for treating ATS use disorder.
METHODS: Participants with opioid and ATS dependence (N = 69) were enrolled in a pilot, double-blind, placebo-controlled randomized clinical trial; all received buprenorphine/naloxone and behavioral counseling and were randomized to atomoxetine 80 mg daily (n = 33) or placebo (n = 33). The effect size of the between-group difference on the primary outcome, proportion of ATS-negative urine tests, was estimated using Cohen's d for the intention-to-treat (ITT) sample and for higher adherence subsample (≥60 days of atomoxetine or placebo ingestion).
RESULTS: Participants were all male with mean (SD) age 39.4 (6.8) years. The proportion of ATS-negative urine tests was higher in atomoxetine- compared to placebo-treated participants: 0.77 (0.63-0.91) vs. 0.67 (0.53-0.81, d = 0.26) in the ITT sample and 0.90 (0.75-1.00) vs. 0.64 (0.51-0.78, d = 0.56) in the higher adherence subsample. The proportion of days abstinent from ATS increased from baseline in both groups (p 
Kratom and Pain Tolerance: A Randomized, Placebo-Controlled, Double-Blind Study

Vicknasingam B, Chooi WT, Rahim AA, Ramachandram D, Singh D, Ramanathan S, et al.

Yale J Biol Med, 2020 06;93(2):229-238.
PMID: 32607084

Background: Kratom has a long history of traditional medicine use in Southeast Asia. Consumption of kratom products has also been reported in the US and other regions of the world. Pain relief is among many self-reported kratom effects but have not been evaluated in controlled human subject research. Methods: Kratom effects on pain tolerance were assessed in a randomized, placebo-controlled, double-blind study. During a 1-day inpatient stay, participants received a randomized sequence of kratom and placebo decoctions matched for taste and appearance. Pain tolerance was measured objectively in a cold pressor task (CPT) as time (seconds) between the pain onset and the hand withdrawal from the ice bath. Health status, vital signs, objective, and subjective indicators of withdrawal symptoms, self-reported data on lifetime kratom use patterns, and assessments of blinding procedures were also evaluated. Results: Twenty-six males with the mean (SD) age 24.3 (3.4) years were enrolled. They reported the mean (SD) 6.1 (3.2) years of daily kratom consumption. Pain tolerance increased significantly 1 hour after kratom ingestion from the mean (SD) 11.2 (6.7) seconds immediately before to 24.9 (39.4) seconds 1 hour after kratom consumption (F(2,53.7)=4.33, p=0.02). Pain tolerance was unchanged after consuming placebo drinks: 15.0 (19.0) seconds immediately before and 12.0 (8.1) seconds 1 hour after consumption of placebo (F(2,52.8)=0.93, p=0.40). No discomfort or signs of withdrawal were reported or observed during 10-20 hours of kratom discontinuation. Conclusions: Kratom decoction demonstrated a substantial and statistically significant increase in pain tolerance. Further rigorous research on kratom pain-relieving properties and a safety profile is needed.
Evaluation of toxicity profile of kratom (Mitragyna speciosa Korth) decoction in rats

Hassan Z, Singh D, Suhaimi FW, Chear NJ, Harun N, See CP, et al.

Regul Toxicol Pharmacol, 2023 Sep;143:105466.
PMID: 37536550 DOI: 10.1016/j.yrtph.2023.105466

Mitragyna speciosa Korth also known as kratom, is an herbal drug preparation for its therapeutic properties and opioid-replacement therapy. Kratom is consumed in a brewed decoction form in Malaysia and to date, no studies have characterized its chemical and toxicity profile. Thus, this study aims to evaluate kratom decoction's safety and toxicity profile after 28 days of treatment. Mitragynine content was quantified in kratom decoction and used as a marker to determine the concentration. Male and female Sprague Dawley rats were orally treated with vehicle or kratom decoction (10, 50 or 150 mg/kg) and two satellite groups were treated with vehicle and kratom decoction (150 mg/kg). Blood and organs were collected for hematology, biochemical and histopathology analysis at the end of treatment. No mortality was found after 28 days of treatment and no significant changes in body weight and hematology profile, except for low platelet count. High amounts of uric acid, AST, ALT and alkaline phosphatase were found in the biochemical analysis. Histological investigation of the heart and lungs detected no alterations except for the kidney, liver and brain tissues. In conclusion, repeated administration of kratom decoction provided some evidence of toxicity in the kidney and liver with no occurrence of mortality.

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