Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

Completed · Phase 1

Conditions studied: Nicotine Dependence, Opiate Dependence

In brief

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. .

Key facts

Study ID

NCT01393392

Run by

Rutgers, The State University of New Jersey

People needed

87

Starts

2011-10-01

Expected to finish

2014-05-01

Last updated by the study team

2018-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Enrolled in methadone treatment for at least three months
• Able to give informed consent
• Willing and able to participate in all study activities
• Smoked at least 100 cigarettes during their lifetime
• Currently smoke every day or most days
• Has access to a working telephone
• Interested in participating in a smoking cessation intervention and quitting smoking within the next six months

You may not qualify if…

• Unable to speak English fluently
• Took smoking cessation related medication or participated in smoking cessation counseling in the past three months
• Pregnant or breastfeeding or planning on becoming pregnant or breastfeeding during the next six months

Where it is running

• Rutgers Robert Wood Johnson Medical School — New Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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