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Baclofen Effects on Smoking Urge and Withdrawal

NCT00257894 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2015-11-04

Study results available
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Summary

The purpose of this study is to determine whether baclofen is effective in reducing smoking urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.

Conditions

  • Nicotine Use Disorder
  • Nicotine Dependence
  • Smoking
  • Tobacco Use Disorder

Interventions

DRUG

Baclofen

Dosing taken orally for a total of 12 days: 40mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12).

DRUG

Placebo

Matched placebo capsules containing inert filler taken orally for a total of 12 days

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Damaris Rohsenow, PhD · VA Medical Center, Providence

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00257894 on ClinicalTrials.gov