CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 87 enrolled
Drug / intervention
Intensive, tailored intervention +1 morebehavioral
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/NCT01393392
NCT01393392Phase 1Completed

Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

Rutgers, The State University of New Jersey·interventional·Posted Jul 13, 2011·Updated Sep 6, 2018

In Brief

A Phase 1 clinical trial evaluating Intensive, tailored intervention and NJ Quitline Referral for Nicotine Dependence and Opiate Dependence. Completed, enrolled 87 participants across 1 site.

Detailed Summary

The purpose of this study is to pilot and evaluate, in a randomized controlled trial, the immediate and long-term effects of a newly developed, tailored, intensive smoking cessation intervention among methadone maintained smokers and compared to a control condition (facilitated referral to the NJ Quitline). The newly developed intervention is evidence based, addresses the unique needs of methadone maintained smokers, is intensive, can be tailored to the individual, and builds on the strengths as well as addresses the gaps in previous treatments for methadone maintained smokers. The investigators hypothesize that: (1) three months and six months after beginning treatment, those in the tailored intervention condition will be more likely to be abstinent from smoking than those in the control intervention condition (primary outcome); (2) there will be a greater relapse rate in the control intervention condition between the three and six month follow-up points than in the tailored intervention condition; (3) three and six months after beginning treatment, those in the tailored intervention condition will have better secondary smoking related outcomes (smoked fewer cigarettes per day in the past week, be more ready to quit, have greater self-efficacy for quitting, experience less nicotine dependence, and be more likely to have made a quit attempt) than those in the control intervention condition; (4) three and six months after beginning treatment, those in the tailored intervention condition will have better utilization of and adherence to smoking cessation pharmacotherapy, better mental and physical health, less perceived stress, greater social support, less drug and alcohol use, and greater involvement in drug and alcohol treatment than those in the control intervention condition; and (5) the newly created tailored intervention will be feasible and acceptable. .

Study Details

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

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2011
Enrollment StartOct 1, 2011
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.0 years ago

Interventions

Intensive, tailored interventionbehavioral

Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.

NJ Quitline Referralbehavioral

Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).