Tobacco Intervention in Buprenorphine Treatment

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:

1. We hypothesize that at months 12 and 18, participants in IS will attain higher
biochemically verified cigarette abstinence rates than those in STC.

2. 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.

3. 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.

4. 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.

5. 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.

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.