Maintaining Nonsmoking

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 3

Conditions: Nicotine Dependence

Treatments: Behavioral: Check-ins with medical staff; Behavioral: Extended Individual Counseling - Health Model; Behavioral: Initial Individual counseling; Behavioral: Extended Individual Counseling - Relapse Prevention Model; Drug: Varenicline

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01162239

2R01DA002538 (U.S. NIH Grant/Contract)

DA002538

11633 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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216 participants in 4 patient groups

Extended Brief Contact

Experimental group

Description:

Following standard brief treatment, participants have monthly meetings with medical staff.

Treatment:

Behavioral: Check-ins with medical staff

Drug: Varenicline

Behavioral: Initial Individual counseling

Extended Health Education

Experimental group

Description:

Following standard treatment, participants receive monthly counseling with content based on a health education model.

Treatment:

Drug: Varenicline

Behavioral: Initial Individual counseling

Behavioral: Extended Individual Counseling - Health Model

Extended Relapse Prevention plus varenicline

Experimental group

Description:

Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.

Treatment:

Behavioral: Extended Individual Counseling - Relapse Prevention Model

Drug: Varenicline

Behavioral: Initial Individual counseling

Extended Relapse Prevention

Experimental group

Description:

Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.

Treatment:

Behavioral: Extended Individual Counseling - Relapse Prevention Model

Drug: Varenicline

Behavioral: Initial Individual counseling