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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00733967 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Methamphetamine Addiction |
Drug: Varenicline Drug: placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline In Methamphetamine-Dependent Volunteers Receiving Methamphetamine |
| Estimated Enrollment: | 13 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: I
Placebo capsules as control
|
Drug: placebo
placebo treatment daily
|
|
Experimental: II
Varenicline
|
Drug: Varenicline
Varenicline: 0.5 mg once daily for 3 days; 0.5 twice daily for 2 days; 1 mg twice daily for one day; 1 mg once daily for one day
Other Name: Chantix
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Richard De La Garza, PhD | 713-791-1414 ext 6020 | rg12@bcm.tmc.edu |
| Contact: Thomas F. Newton, MD | 713-791-1414 ext 6498 | tnewton@bcm.edu |
| United States, Texas | |
| Michael E. DeBakey VA Medical Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Richard De La Garza, II, PhD | Baylor College of Medicine |
More Information
| Responsible Party: | Dr. Richard De La Garza, II, Baylor College of Medicine |
| ClinicalTrials.gov Identifier: | NCT00733967 History of Changes |
| Other Study ID Numbers: | H-22707 |
| Study First Received: | August 11, 2008 |
| Last Updated: | April 23, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
methamphetamine chantix varenicline |
|
Behavior, Addictive Compulsive Behavior Impulsive Behavior Methamphetamine Amphetamine Varenicline Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors Nicotinic Agonists Cholinergic Agonists Cholinergic Agents |