Clinical trial NCT01162239: Maintaining Nonsmoking
Official title: Maintaining Nonsmoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nicotine Dependence
Keywords: Smoking
Tobacco
Nicotine
Smoking cessation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Pfizer
First posted: 2010-07-14
Enrollment: 216
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: The research is based on a chronic disorder model of cigarette smoking which suggests that long-term treatment targeted to prevent relapse may be useful. Based on this model, the investigators have developed a relapse prevention treatment to intervene on five areas important in relapse prevention, including fluctuating motivation, depression, withdrawal, weight gain, and social support. This treatment protocol has produced high long-term abstinence rates when implemented in a clinical research setting. The current study will evaluate the treatment model when implemented in a medical outpatient setting.

Detailed description: This study will test a series of hypotheses comparing the efficacy of the relapse prevention treatment to other extended treatments. All participants will be assessed at baseline on demographics, smoking behaviors, nicotine dependence, depression, alcohol and other drug history and problems, mood disturbance, treatment support, stress, health status, and motivation for change. Participants will be randomly assigned to one of four treatment conditions. All participants will receive 12 weeks of combined pharmacological treatment (varenicline) and behavioral treatment (five individual counseling sessions). Following this brief treatment, participants will be randomly assigned to one of four treatment protocols

1. Monthly Brief Contact or
2. Extended Non-Specific Behavioral Treatment or
3. Extended Relapse Prevention Treatment or
4. Extended Relapse Prevention Treatment + availability of varenicline treatment.

Each extended treatment protocol is 40 weeks in duration following the initial 12 weeks of treatment.

All participants will be assessed at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Must be smoking 5 or more cigarettes per day

Exclusion Criteria:

* Previous history of bipolar/manic-depressive disorder
* Current diagnosis of schizophrenia
* Acute life threatening diseases
* Evidence of alcohol or other drug abuse so severe that the patient is judged to be potentially unable to comply with the protocol
* Pregnancy or lactation
* Individuals with out of normal range blood pressure, active angina, valve disease, valve replacement, active cardiomyopathies, myocardial infarction or Coronary artery bypass grafting (CABG) within one year, and Congestive heart failure (CHF)

Primary outcomes:
measure: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12
timeFrame: 12 weeks following treatment initiation
measure: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24
timeFrame: 24 weeks following treatment initiation
measure: Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52
timeFrame: 52 weeks following treatment initiation
measure: Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64
timeFrame: 64 weeks following treatment initiation
measure: Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104
timeFrame: 104 weeks following treatment initiation
Secondary outcomes:
measure: Comparison of Combined Extended vs Brief Treatment at Week 24
timeFrame: 24 weeks following treatment initiation
measure: Comparison of Combined Extended vs Brief Treatment at Week 52
timeFrame: 52 weeks following treatment initiation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Gary Humfleet, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: