CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Baclofen +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01821560
NCT01821560Phase 2Completed

Baclofen Effects on Brain and Behavior in Cigarette Smokers

University of Pennsylvania·interventional·Posted Apr 1, 2013·Updated Dec 19, 2018

In Brief

A Phase 2 clinical trial evaluating Baclofen and placebo for Nicotine Dependence. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The proposed project will utilize perfusion functional magnetic resonance imaging (fMRI), a functional candidate gene association approach (of dopaminergic addictions-targeted polymorphisms), and the dopamine-modulating and gamma-aminobutyric acid (GABA) B receptor agonist, baclofen, to examine the brain and behavioral responses in smokers to appetitive smoking reminders (cues that motivate continued smoking and relapse). These studies will provide a means to identify an appetitive cue-sensitive pharmacologic-responsive endophenotype. Once brain/behavioral/genetic endophenotypes can be determined prior to treatment, smoking cessation treatments can be structured to meet individual needs, which will significantly improve treatment outcome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2013
Enrollment StartMar 1, 2013
Primary CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.3 years ago

Interventions

Baclofendrug

placebodrug