Clinical trial NCT01350011: Tobacco Intervention in Buprenorphine Treatment
Official title: Extended Tobacco Dependence Intervention in Buprenorphine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Dependence
Keywords: Nicotine Replacement Therapy
Buprenorphine
Varenicline
Smoking Cessation
Addiction
The Innovative System (IS) Treatment
The Standard Treatment Control (STC)
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-05-09
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Smoking Status
timeFrame: 3, 6, 12, and 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Behavioral Health Access Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sharon Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall SM, Humfleet GL, Gasper JJ, Delucchi KL, Hersh DF, Guydish JR. Cigarette Smoking Cessation Intervention for Buprenorphine Treatment Patients. Nicotine Tob Res. 2018 Apr 2;20(5):628-635. doi: 10.1093/ntr/ntx113.