Varenicline as a Treatment for Methamphetamine Dependence (Varenicline)
|ClinicalTrials.gov Identifier: NCT01571167|
Recruitment Status : Completed
First Posted : April 5, 2012
Last Update Posted : June 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Methamphetamine Dependence Methamphetamine Abuse Substance Abuse||Drug: Placebo Drug: Varenicline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline in Methamphetamine-Dependent Volunteers Receiving Methamphetamine|
|Study Start Date :||January 2011|
|Primary Completion Date :||February 2012|
|Study Completion Date :||February 2012|
|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
- The effects of varenicline and methamphetamine on safety and cardiovascular measures [ Time Frame: On study day 6 and 7 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|