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Varenicline as a Treatment for Methamphetamine Dependence

NCT01571167 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2013-06-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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).

DRUG

Varenicline

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.

DRUG

Varenicline

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.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Richard De La Garza, II, PhD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01571167 on ClinicalTrials.gov