NCT00733967

Varenicline-Methamphetamine Interaction Study (2008)

A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline In Methamphetamine-Dependent Volunteers Receiving Methamphetamine

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The primary aim of the study is to determine the safety and tolerability of treatment with Varenicline in methamphetamine-dependent volunteers. The investigators also seek to determine the effects of treatment with Varenicline, as compared to placebo, on craving for methamphetamine or cigarettes following exposure to methamphetamine and smoking cues, respectively. The effects of treatment with Varenicline, as compared to placebo, on subjective effects produced by administration of methamphetamine or placebo will be attempted to be determined. Lastly, the investigators hope to determine the effects of treatment with Varenicline, as compared to placebo, on reinforcing effects produced by administration of methamphetamine or placebo.

Detailed description

See Brief Summary

Conditions

• Methamphetamine Dependence
• Substance Abuse
• Methamphetamine Abuse

Interventions

Type	Name	Description
DRUG	Varenicline	Varenicline (oral capsule): 0.5 mg once daily for 3 days; 0.5 mg twice daily for 2 days; 1 mg twice daily for one day; 1 mg once daily for one day.
DRUG	Placebo	Matching oral placebo capsules as control.

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2008-08-13
• Last updated: 2012-07-27