Phase 2 N=20 Randomized Quadruple-blind Treatment

Varenicline vs Placebo for the Treatment of Methamphetamine Dependence

Methamphetamine Dependence · Substance Abuse · Methamphetamine Abuse

Bottom Line

View on ClinicalTrials.gov: NCT01011829 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcome: Primary: Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo. — 7.4; 2.3 total MA-free urine drug screens

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Varenicline (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo.	7.4; 2.3	—
SECONDARY Retention (Completion)	6; 1	—

Summary

Methamphetamine (MA) abuse is the fastest growing drug problem in the United States and is responsible for significant public health complications, including HIV infection. As a result effective treatments for MA dependence are urgently needed. There are currently no efficacious medications for MA dependence, although results from preliminary randomized trials of bupropion for MA dependence found bupropion to be more effective than placebo, but only among subgroups of participants, including those with lower frequency of MA use at baseline. A growing body of preclinical and clinical studies suggest that cholinergic mechanisms play an important role in the neurobiology of MA and other stimulant dependence, such as nicotine dependence. Mechanistically, cholinergic medications may alleviate MA-associated cognitive dysfunction, thereby improving outcomes of treatment for MA dependence. Varenicline is a partial agonist at α4β2 nicotinic receptors and a full agonist at α7 nicotinic receptors that has been approved as an anti-cigarette smoking medication. In order to assess the potential efficacy of varenicline for methamphetamine dependence, we will perform a clinical trial to assess if varenicline compared to placebo results in greater: 1. reductions in methamphetamine use; 2. treatment retention;

Eligibility Criteria

Inclusion Criteria

18 years of age or older;
meet (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria for methamphetamine (MA) dependence;
seeking treatment for MA problems;
willing and able to comply with study procedures;
willing and able to provide written informed consent;
if female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) during the trial.

Exclusion Criteria

have a medical condition that, in the study physician's judgment, may interfere with safe study participation (e.g., active tuberculosis, unstable cardiac, renal, or liver disease, uncontrolled hypertension, unstable diabetes);
have a current neurological disorder (e.g., organic brain disease, dementia) or a medical history which would make study agent compliance difficult or which would compromise informed consent;
have a current major psychiatric disorder not due to substance abuse (e.g., schizophrenia, bipolar disorder) as assessed by the Structured Clinical Interview for DSM Disorders (SCID);
have a history of attempted suicide in the past 3 years and/or serious suicidal intention or plan in the past year as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS);
currently on prescription medication that is contraindicated for use with varenicline;
currently using any form of nicotine replacement therapy, due to potential interactions with varenicline;
have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV;
have a history of alcohol dependence within the past three years;
have a history of sensitivity to varenicline or any other circumstances that, in the opinion of the investigators, would compromise participant safety.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01011829). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.