Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

NCT01393392 | Completed Phase 1 Results DMC

• 1 other identifier: K23DA025049
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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. .

Conditions

Nicotine Dependence; Opiate Dependence

Keywords

smoking cessation; methadone treatment; nicotine addiction; drug treatment; drug addiction; tobacco dependence

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experienced Seven-day Point Prevalence Smoking Abstinence

  Self-reported not smoking "even a puff" within the previous seven days, and exhaled carbon monoxide reading of \<8 parts per million.

  during the previous seven days at three months post baseline

Secondary Outcomes (5)

• Median Number of Cigarettes Participants Smoked Per Day During the Past Week

  during the previous seven days at three months post baseline

• Number of Participants Who Experienced Any Quit Attempts Since Baseline

  During the period between baseline and three months post enrollment

• Number of Participants Who Experienced Seven-day Point Prevalence of Smoking Abstinence

  during the previous seven days at six months post baseline

• Median Number of Cigarettes Smoked Per Day During the Past Week

  during the previous seven days at six months post baseline

• Number of Participants Who Experienced Any Quit Attempts Since Enrollment

  during the period between baseline and six months post-enrollment

Study Arms (2)

Intensive, tailored intervention

EXPERIMENTAL

Participants in the intensive intervention condition will receive eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the methadone clinic. Participant treatment needs will be assessed during the first session and the intervention will be tailored to the participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.

Behavioral: Intensive, tailored intervention

Control Intervention

ACTIVE COMPARATOR

Participants randomized to the control intervention will receive a referral to the NJ Quitline (a telephone smoking cessation counseling service). Participants will receive a brochure and information about the referral. Study staff will contact the NJ Quitline for control participants, and a counselor from the Quitline will call control participants.

Behavioral: NJ Quitline Referral

Interventions

Intensive, tailored intervention BEHAVIORAL

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.

Also known as: Smokers in Methadone Treatment Intervention, IMB Model Based Smoking Cessation Intervention

Intensive, tailored intervention

NJ Quitline Referral BEHAVIORAL

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

Also known as: Standard of Care Smoking Cessation Intervention, General Population Smoking Cessation Intervention

Control Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Opioid-Related Disorders; Smoking Cessation; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Nina Cooperman
• Organization: Rutgers Robert Wood Johnson Medical School

cooperna@rwjms.rutgers.edu

732-235-8569

Study Officials

• Nina Cooperman, Psy.D.

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: July 13, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: September 6, 2018
• Results First Posted: September 6, 2018

Record last verified: 2018-09

Locations

US (1)