Maintaining Nonsmoking

Nicotine Dependence Clinical Trial

Official title:

Maintaining Nonsmoking

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162239
• Other study ID #: DA002538
• Secondary ID: 2R01DA0025381163
• Status: Completed
• Phase: Phase 3
• Start date: May 2010
• Est. completion date: June 2016

Study information

• Verified date: October 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Varenicline
All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.

Behavioral:
• Initial Individual counseling
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
• Check-ins with medical staff
Monthly brief (10-15 minutes) meetings with medical staff.
• Extended Individual Counseling - Health Model
Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.
• Extended Individual Counseling - Relapse Prevention Model
Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA), Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12	Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 parts per million (ppm)) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.	12 weeks following treatment initiation
Primary	Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24	Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.	24 weeks following treatment initiation
Primary	Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52	Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.	52 weeks following treatment initiation
Primary	Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64	Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.	64 weeks following treatment initiation
Primary	Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104	Point prevalent abstinence is defined as biochemically verified (confirmed carbon dioxide (CO) < 8 ppm) self-reported abstinence from smoking cigarettes in the past 7 days. Smoking status was then categorized as either Abstinent or Not Abstinent.	104 weeks following treatment initiation
Secondary	Comparison of Combined Extended vs Brief Treatment at Week 24	The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis.	24 weeks following treatment initiation
Secondary	Comparison of Combined Extended vs Brief Treatment at Week 52	The three extended treatment programs were combined and compared to the Brief treatment, with extended treatments expected to produce significant higher CO corrected abstinence rates overall. Comparisons will be tested using Chi-Square analysis.	52 weeks following treatment initiation