CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 96 enrolled
Drug / intervention
Transdermal Nicotine Patch +2 moredrug
Likely dose
Transdermal Nicotine Patch 7 mgfrom 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/NCT01372254
NCT01372254Phase 2Completed

Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

University of Maryland, College Park·interventional·Posted Jun 13, 2011·Updated May 18, 2022

In Brief

A Phase 2 clinical trial evaluating Standard Treatment, BAD-AS, and 1 other intervention for Cigarette Smoking and Drug Use. Completed, enrolled 96 participants across 1 site.

Detailed Summary

The objective of the proposed project is to develop a novel, behavioral approach to smoking cessation that can be integrated with residential drug use treatment for low income substance using smokers with elevated depressive symptoms. The approach utilizes behavioral activation strategies which have been shown to reduce smoking among community samples and which can be easily targeted for the particular needs of low income substance users.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 13, 2011
Enrollment StartDec 1, 2011
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.1 years ago

Interventions

Standard Treatmentbehavioral

Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.

BAD-ASbehavioral

The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.

Transdermal Nicotine Patchdrug

8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch.