Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-07-21 @ 4:03 AM
Study NCT ID:
NCT01571167
Status:
COMPLETED
Last Update Posted:
2013-06-13
First Post:
2012-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Varenicline as a Treatment for Methamphetamine Dependence
Sponsor:
Baylor College of Medicine
Organization:
Study Overview
Official Title:
A Human Laboratory Assessment of the Safety and Potential Efficacy of Varenicline in Methamphetamine-Dependent Volunteers Receiving Methamphetamine
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Varenicline
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| DPMC | OTHER | NIDA | View | |
| 1R01DA027134-01 | NIH | None | https://reporter.nih.gov/quic… | View |