Varenicline as a Treatment for Methamphetamine Dependence
The primary purpose of the study is to determine the effects of treatment with varenicline (1 and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving and subjective effects in methamphetamine-dependent human volunteers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline in Methamphetamine-Dependent Volunteers Receiving Methamphetamine|
- The effects of varenicline and methamphetamine on safety and cardiovascular measures [ Time Frame: On study day 6 and 7 ] [ Designated as safety issue: Yes ]The safety of MA administration during treatment will be assessed by reporting of adverse events (AEs), and using ECG recording, and heart rate and blood pressure measurements. Digital 12-lead ECG will also be recorded prior to randomization. Blood pressure and heart rate will be measured from 15 min prior to MA or placebo dosing until 2 h after dosing. In addition, heart rate and blood pressure will be assessed throughout the inpatient portion of the protocol.
- The effects of varenicline and methamphetamine on subjective effects [ Time Frame: On study day 6 and 7 ] [ Designated as safety issue: No ]Efficacy will be assessed by measuring effects of treatment on subjective effects produced by administration of MA. Patients will complete visual analog scale (VAS) ratings at T= 5, 15, 30, 60, 120, 240 and 360 min post dosing. Other diagnostic measures and assessment instruments will be used to further characterize the study population.
|Study Start Date:||January 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
Participants will receive varenicline or matched placebo from day 1 through day 7, then the same subjects will return within 2-4 weeks and assigned to each of the two remaining study medication conditions, and undergo the identical procedures (3-phase study).
Other Name: Sugar pill
|Active Comparator: Varenicline 2 mg||
For varenicline 2 mg, dosing will begin at 0.5 mg once daily for days 1-3 (with 0 mg placebo to maintain blind of bid dosing), will be increased to 0.5 mg twice daily for day 4, and increased to 1 mg twice daily on days 5-6, and then reduced to 1 mg once daily on day 7. No medication is given on Day 8.
Other Name: Chantix
|Active Comparator: Varenicline 1 mg||
For varenicline 1 mg, dosing will begin at 0.5 mg once daily (with 0 mg placebo to maintain blind of bid dosing) for days 1-3, will be increased to 0.5 mg twice daily for the days 4-6, and then reduced to 0.5 mg once daily on day 7. No medication is given on Day 8.
Other Name: Chantix
This study is part of an effort to develop treatments for methamphetamine abuse. Varenicline is a drug that changes levels of certain brain chemicals that may also be useful in helping people to stop using methamphetamine. Our goal is to determine the safety and effects of varenicline (1 and 2 mg, daily, vs. a placebo) when it is used before experimental administration of methamphetamine, on a number of physical and psychological measures; specifically blood pressure, heart rate, and how you feel after taking methamphetamine. The secondary purpose is to determine the effects of treatment with varenicline (1 and 2 mg daily), compared to treatment with placebo, on the reinforcing effects of methamphetamine by measuring methamphetamine self-administration in methamphetamine-dependent human volunteers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571167
|United States, Texas|
|Michael E. DeBakey Veterans Affairs Medical Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Richard De La Garza, II, PhD||Baylor College of Medicine|