Maintaining Nonsmoking
Status: | Active, not recruiting |
---|---|
Conditions: | Smoking Cessation, Tobacco Consumers |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | May 2010 |
End Date: | July 2017 |
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. 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. All participants will be assessed
at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.
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. 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. All participants will be assessed
at weeks 12, 24, 52, 64, and 104, on smoking as well as other psychometric measures.
Inclusion Criteria:
- 18 years of age
- smoking 5 or more cigarettes per day
Exclusion Criteria:
- history of bipolar/manic-depressive disorder
- schizophrenia
- acutely 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
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