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Varenicline treatment for methamphetamine dependence: A randomized, double-blind phase II clinical trial.

ABSTRACT: BACKGROUND:Previous studies have suggested that varenicline, an ?4?2 nicotinic receptor partial agonist, and ?7 nicotinic receptor full agonist, may be effective for the treatment of methamphetamine (MA) dependence due to dopaminergic effects, relief of glutamatergic and cognitive dysfunction, and activation of nicotinic cholinergic systems. This study aimed to determine if varenicline (1?mg BID) resulted in reduced methamphetamine use compared to placebo among treatment-seeking MA-dependent volunteers. METHODS:Treatment-seeking MA-dependent volunteers were randomized to varenicline 1?mg twice daily (n?=?27) or placebo (n?=?25) and cognitive behavioral therapy for 9?weeks. The primary outcomes were the proportion of participants achieving end-of-treatment-abstinence (EOTA, MA-negative urine specimens during weeks 8 and 9) and the treatment effectiveness score (TES, number of MA-negative urine specimens) for varenicline versus placebo. RESULTS:There was no significant difference in EOTA between varenicline (15%, 4/27) and placebo (20%, 5/25; p?=?0.9). There was some suggestion that urinary confirmed medication compliance corresponded with EOTA in the varenicline condition, though it did not reach statistical significance, OR?=?1.57 for a 100?ng/ml increase in urine varenicline, p?=?0.10, 95% CI (0.99, 3.02). There was no significant difference in mean TES in the varenicline condition (8.6) compared to the placebo condition (8.1), and treatment condition was not a statistically significant predictor of TES, IRR?=?1.01, p?=?0.9, 95% CI (0.39, 2.70). CONCLUSIONS:The results of this study indicate that 1?mg varenicline BID was not an effective treatment for MA dependence among treatment-seeking MA-dependent volunteers.

SUBMITTER: Briones M

PROVIDER: S-EPMC6391991 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Varenicline treatment for methamphetamine dependence: A randomized, double-blind phase II clinical trial.

Briones Marisa M Shoptaw Steven S Cook Ryan R Worley Matthew M Swanson Aimee-Noelle AN Moody David E DE Fang Wenfang B WB Tsuang John J Furst Benjamin B Heinzerling Keith K

Drug and alcohol dependence 20180525

<h4>Background</h4>Previous studies have suggested that varenicline, an α4β2 nicotinic receptor partial agonist, and α7 nicotinic receptor full agonist, may be effective for the treatment of methamphetamine (MA) dependence due to dopaminergic effects, relief of glutamatergic and cognitive dysfunction, and activation of nicotinic cholinergic systems. This study aimed to determine if varenicline (1 mg BID) resulted in reduced methamphetamine use compared to placebo among treatment-seeking MA-depen ...[more]

PMID: 29860057

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Project description:IntroductionMethamphetamine dependence is a growing public health concern. There is currently no pharmacotherapy approved for methamphetamine dependence. Lisdexamfetamine (LDX) dimesylate, used in the treatment of attention-deficit hyperactivity disorder and binge eating disorder, has potential as an agonist therapy for methamphetamine dependence, and possible benefits of reduced risk of aberrant use due to its novel formulation.Methods and analysisA double-blind randomised controlled trial will be used to evaluate the efficacy of LDX in reducing methamphetamine use. The target sample is 180 participants with methamphetamine dependence of ≥2 years, using ≥14 days out of the previous 28, who have previously attempted but not responded to treatment for methamphetamine use. Participants will be randomly assigned to receive either a 15-week intervention consisting of induction (1 week of 150 mg LDX or placebo), maintenance (12 weeks of 250 mg LDX or placebo) and reduction (1 week of 150 mg LDX or placebo and 1 week of 50 mg LDX or placebo). All participants will be given access to four sessions of cognitive-behavioural therapy as treatment as usual and receive a 4-week follow-up appointment. The primary outcomes are efficacy (change from baseline in days of methamphetamine use by self-report for the last 28 days at week 13 and urinalyses confirmation of methamphetamine use) and safety (treatment-related adverse events). Secondary outcomes are total number of days of self-report methamphetamine use over the 12-week active treatment, longest period of abstinence during treatment period, percentage of achieving ≥21 days abstinence, craving, withdrawal, dependence, retention, bloodborne virus transmission risk behaviour, criminal behaviour, as well measures of abuse liability, physical and mental health, other substance use, cognitive performance, psychosocial functioning, treatment retention and satisfaction. Additionally, the study will assess the cost-effectiveness of LDX relative to the placebo control.Ethics and disseminationThe study has been approved by the Human Research Ethics Committee of St. Vincent's Hospital, Sydney, Australia (HREC/16/SVH/222). Contact the corresponding author for the full trial protocol.Trial registration numberACTRN12617000657325; Pre-results.

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Varenicline treatment for methamphetamine dependence: A randomized, double-blind phase II clinical trial.

Publications

Varenicline treatment for methamphetamine dependence: A randomized, double-blind phase II clinical trial.

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