Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT01393392
First received: June 27, 2011
Last updated: February 14, 2014
Last verified: February 2014
  Purpose

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. .


Condition Intervention Phase
Nicotine Dependence
Opiate Dependence
Behavioral: Intensive, tailored intervention
Behavioral: NJ Quitline Referral
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Developing a Smoking Cessation Intervention for Methadone Maintained Smokers

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • seven-day point prevalence of smoking abstinence [ Time Frame: three months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mean number of cigarettes smoked per day during the past week [ Time Frame: three months and six months ] [ Designated as safety issue: No ]
  • any quit attempts since enrollment [ Time Frame: three months and six months ] [ Designated as safety issue: No ]
  • readiness for quitting [ Time Frame: three months and six months ] [ Designated as safety issue: No ]
  • self-efficacy for quitting [ Time Frame: three months and six months ] [ Designated as safety issue: No ]
    Participant's rating of confidence in ability to quit smoking on a scale from 0 (not at all confident) to 10 (extremely confident).

  • nicotine dependence [ Time Frame: three months and six months ] [ Designated as safety issue: No ]
  • three-month prolonged smoking abstinence [ Time Frame: six months ] [ Designated as safety issue: No ]
  • seven-day point prevalence of smoking abstinence [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 118
Study Start Date: October 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive, tailored intervention
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
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.
Other Names:
  • Smokers in Methadone Treatment Intervention
  • IMB Model Based Smoking Cessation Intervention
Active Comparator: Control Intervention
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
Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
Other Names:
  • Standard of Care Smoking Cessation Intervention
  • General Population Smoking Cessation Intervention

Detailed Description:

Most individuals in methadone maintenance treatment are tobacco smokers. Also, people in methadone treatment are more likely to experience the health issues related to smoking than the general population. Yet, research has found that smokers receiving methadone treatment are interested in quitting and receiving tobacco cessation treatment, and people in drug treatment who quit smoking are less likely to use drugs.

To better help methadone maintained smokers quit smoking and prevent them from starting smoking again, we want to evaluate the effects of a new smoking cessation counseling intervention, designed for methadone maintained smokers as compared to a smoking cessation counseling intervention used with the general population.

Eligible participants will:

  • Be English speaking (i.e., able to participate in counseling sessions in English and to complete study interviews in English);
  • Be enrolled in methadone treatment for at least three months;
  • Be able to give informed consent;
  • Be willing and able to participate in all study activities;
  • Not have taken smoking cessation related medication or participated in smoking cessation counseling in the past six months;
  • Have smoked at least 100 cigarettes during their lifetime and currently smoke every day or most days;
  • Not currently be pregnant or breastfeeding or plan on getting pregnant or breastfeeding during the next six months;
  • Have access to a working telephone; and,
  • Be interested in participating in a smoking cessation intervention and quitting smoking within the next six months.

Participants will be randomly assigned to receive either a smoking cessation intervention tailored for methadone maintained smokers or a referral to a smoking cessation program available to the general population (NJ Quitline). Participants assigned to receive the tailored intervention, will participate in approximately eight individual counseling sessions, with a smoking cessation counselor, over three months. Each session will last approximately 45 minutes and occur in the participant's methadone clinic. Treatment needs will be assessed during the first session and the intervention will be tailored to participants' needs. Prior to quitting participants will receive nicotine replacement patches and lozenges and instructions on how to use them.

Study staff will contact the NJ Quitline for participants assigned to the control condition, and a counselor from the Quitline will call them.

Regardless of treatment assignment, participants will be asked to provide a urine sample for a drug test and pregnancy test (for women) and complete an interview, using a computer or face-to-face, before beginning treatment or receiving the NJ Quitline referral and three months and six months after study enrollment.Each interview will take approximately 45 minutes to one hour to complete.

Participants will receive a $20 gift card for completing each research visit (i.e., computer or face-to-face interview), but will not be reimbursed for counseling visits.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01393392

Locations
United States, New Jersey
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Nina Cooperman, Psy.D. Rutgers Robert Wood Johnson Medical School
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT01393392     History of Changes
Other Study ID Numbers: K23DA025049, K23DA025049
Study First Received: June 27, 2011
Last Updated: February 14, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
smoking cessation
methadone treatment
nicotine addiction
drug treatment
drug addiction
tobacco dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Smoking
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Habits
Methadone
Nicotine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics
Ganglionic Stimulants
Autonomic Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014