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Completed

NCT Number: NCT01350011

Tobacco Intervention in Buprenorphine Treatment

Drug addiction treatment patients, including those in treatment for opioid dependence, have a high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid treatment patients, those in buprenorphine maintenance. The specific aims of the study are to test the efficacy and the cost effectiveness of the IS.

A secondary aim is obtain preliminary data about differences in use of non-nicotinic drugs between participants who achieve abstinence from cigarettes during the study, and those who do not.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Behavioral Health Access Center

San Francisco, California, 94103, United States

About this study

This component is grounded in the past work of the Center. It continues the tradition of working with complex populations in new settings. However, it addresses the problem that shorter (standard or traditional tobacco dependence) interventions do not appear to work well in this population, and it tests a research-based alternative that has shown effectiveness in prior research. If the Innovative System (IS) that we propose is shown to be effective in this population, this line of research will offer the field a strategy to more effectively address tobacco dependence among persons with non-nicotinic drug abuse disorders. It is an extended treatment, and with appropriate adaptations, could become a continuing care intervention in a variety of health systems using a variety of health care personnel, including pharmacists, primary care physicians & nurses.

Drug addiction treatment patients, including those in treatment for opioid dependence, have a high rate of tobacco dependence, especially cigarette smoking. The proposed study evaluates an Innovative System (IS) for the treatment of tobacco dependence in one group of opioid treatment patients, those in buprenorphine maintenance. The primary specific aims of the proposed study are to test four efficacy hypotheses and to study cost and cost effectiveness of the IS. We will test the following four hypotheses and explore one additional primary aim:

  • We hypothesize that at months 12 and 18, participants in IS will attain higher biochemically verified cigarette abstinence rates than those in STC.
  • We hypothesize that at months 6, 12, and 18, participants in IS will report more quit attempts and more stringent cigarette abstinence goals than participants in STC.
  • We hypothesize that, in both treatment conditions, a higher number of cigarettes smoked at baseline and higher baseline Fagerström Test of Nicotine Dependence (FTND) score will predict a lower probability of abstinence at months 3, 6, 12, and 18.
  • We hypothesize that, in both experimental conditions, participants with smaller Cotinine/3HC (COT/3HC) ratios will be more likely to be abstinent at months 3, 6, 12, and 18, than those with larger ratios.
  • The final primary specific aim is to determine the cost of providing innovative smoking cessation treatment to opiate dependent individuals in buprenorphine treatment and to learn if the treatment is cost-effective, that is, if its benefits are sufficient to justify its cost. This aim reflects an ongoing and historical emphasis in this P50 center grant, that of obtaining cost and cost-effectiveness data, as well as efficacy data A secondary aim is to obtain preliminary data about differences in use of non-nicotinic drugs between participants who achieve abstinence from cigarettes during the study, and those who do not.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All participants must smoke five or more cigarettes a day and be registered patients at Integrated Buprenorphine Intervention Services (IBIS) of the San Francisco Department of Public Health.

Exclusion criteria

  • Participants with contraindications to NRT will be excluded. Thus, participants who have had a myocardial infarction within the last three months, or who have uncontrolled high blood pressure will be excluded. We will exclude pregnant or nursing women.
  • Participants with contraindications to varenicline treatment will be included in the study but will not be eligible for varenicline treatment.

Treatment and study plan

Innovative System

Behavioral

In IS, they will receive motivational counseling at months 3,6,12, and 18. If they decide to quit smoking they will be offered up to 10 sessions of behavioral counseling and access to NRT (nicotine patch and gum) If they relapse on NRT, they will be offered varenicline, if it is not contraindicated.

Standard Treatment Control (STC)

Behavioral

Participants will receive self help information and referrals for counseling and for pharmacological treatment.

Primary outcomes

  1. Smoking Status

    Time frame: 3, 6, 12, and 18 Months

    Smoking status is defined as "no cigarettes for the past 7 days."

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Extended Tobacco Dependence Intervention in Buprenorphine Treatment

Acronym: IBIS

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 9, 2011
Registry last updated
Nov 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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