Substance Abuse Clinical Trial
— RAVENOfficial title:
A Randomized, Double-blind Trial of Varenicline Versus Placebo, in Conjunction With Cognitive Behavioral Therapy, for Methamphetamine Dependence
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;
Status | Completed |
Enrollment | 20 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. 18 years of age or older; 2. meet (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria for methamphetamine (MA) dependence; 3. seeking treatment for MA problems; 4. willing and able to comply with study procedures; 5. willing and able to provide written informed consent; 6. 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: 1. 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); 2. 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; 3. 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); 4. 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); 5. currently on prescription medication that is contraindicated for use with varenicline; 6. currently using any form of nicotine replacement therapy, due to potential interactions with varenicline; 7. have current dependence on cocaine, opiates, alcohol, or benzodiazepines as defined by DSM-IV; 8. have a history of alcohol dependence within the past three years; 9. have a history of sensitivity to varenicline or any other circumstances that, in the opinion of the investigators, would compromise participant safety. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | UCLA Vine Street Clinic | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in MA Positive Urine Drug Screens Among Participants Randomly Assigned to Receive Varenicline Versus Placebo. | Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 24 urine drug screens to provide during the 8 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition. | 8-weeks | No |
Secondary | Retention (Completion) | Retention was determined by the proportion of participants retained for the entire trial and time until drop-out. | 8-weeks | No |
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