Nicotine Dependence
Conditions
Keywords
Smoking, Tobacco, Nicotine, Smoking cessation
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.
Interventions
DRUGVarenicline
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.
BEHAVIORALInitial Individual counseling
Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
BEHAVIORALCheck-ins with medical staff
Monthly brief (10-15 minutes) meetings with medical staff.
BEHAVIORALExtended 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.
BEHAVIORALExtended 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Pfizer
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 | 24 weeks following treatment initiation | 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. |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 | 64 weeks following treatment initiation | 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. |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 | 104 weeks following treatment initiation | 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. |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 | 12 weeks following treatment initiation | 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. |
| Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 | 52 weeks following treatment initiation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Combined Extended vs Brief Treatment at Week 52 | 52 weeks following treatment initiation | 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. |
| Comparison of Combined Extended vs Brief Treatment at Week 24 | 24 weeks following treatment initiation | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from University of California, San Francisco medical clinics and the general community. Participants from the general community were recruited through flyers posted at various community health care organizations and social service agencies. Advertisements were placed in local newspapers and websites.
Pre-assignment details
Participants were stratified based on gender, age, site, and number of cigarettes smoked per day at baseline. Participants were then randomly assigned to one of four treatment conditions derived from a double blinded allocation list prepared by a statistician. Neither participant nor the therapist were unblinded to final treatment until Week 8.
Participants by arm
| Arm | Count |
|---|---|
| Extended Brief Contact Following standard brief treatment, participants have monthly meetings with medical staff.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
Check-ins with medical staff: Monthly brief (10-15 minutes) meetings with medical staff. | 55 |
| Extended Health Education Following standard treatment, participants receive monthly counseling with content based on a health education model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. | 54 |
| Extended Relapse Prevention Plus Varenicline Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model plus access to ongoing medication treatment with varenicline.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. | 52 |
| Extended Relapse Prevention Following standard treatment, participants receive monthly counseling with content based on a relapse prevention model.
Varenicline: All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid.
Individual counseling: Five 90 minute individual counseling sessions.
individual counseling: Eleven individual counseling sessions across a nine month period. Each session is 30-45 minutes in duration. | 55 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Extended Follow-up | Lost to Follow-up | 8 | 13 | 8 | 6 |
| Treatment Phase | Death | 0 | 0 | 0 | 1 |
| Treatment Phase | Lost to Follow-up | 5 | 4 | 2 | 1 |
| Treatment Phase | Withdrawal by Subject | 1 | 3 | 2 | 3 |
Baseline characteristics
| Characteristic | Extended Brief Contact | Extended Health Education | Extended Relapse Prevention Plus Varenicline | Extended Relapse Prevention | Total |
|---|---|---|---|---|---|
| Age, Continuous | 47.3 years STANDARD_DEVIATION 10.8 | 53.8 years STANDARD_DEVIATION 9.4 | 47.0 years STANDARD_DEVIATION 11.6 | 47.3 years STANDARD_DEVIATION 11.8 | 48.9 years STANDARD_DEVIATION 10.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 7 Participants | 1 Participants | 8 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 44 Participants | 49 Participants | 46 Participants | 182 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 8 Participants |
| Number of cigarettes smoked per day 10 or less cigarettes smoked per day | 14 participants | 10 participants | 14 participants | 15 participants | 55 participants |
| Number of cigarettes smoked per day 11 - 22 cigarettes smoked per day | 32 participants | 36 participants | 31 participants | 28 participants | 54 participants |
| Number of cigarettes smoked per day 21 - 30 cigarettes smoked per day | 7 participants | 7 participants | 2 participants | 7 participants | 52 participants |
| Number of cigarettes smoked per day 31 or more cigarettes smoked per day | 2 participants | 1 participants | 5 participants | 5 participants | 55 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 6 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 20 Participants | 14 Participants | 15 Participants | 63 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 4 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 3 Participants | 4 Participants | 7 Participants | 22 Participants |
| Race (NIH/OMB) White | 29 Participants | 24 Participants | 24 Participants | 26 Participants | 103 Participants |
| Region of Enrollment United States | 55 participants | 54 participants | 52 participants | 55 participants | 216 participants |
| Sex: Female, Male Female | 21 Participants | 23 Participants | 18 Participants | 22 Participants | 84 Participants |
| Sex: Female, Male Male | 34 Participants | 31 Participants | 34 Participants | 33 Participants | 132 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 54 | 0 / 52 | 1 / 55 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 2 / 55 | 1 / 54 | 2 / 52 | 2 / 55 |
Outcome results
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.
Time frame: 104 weeks following treatment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Brief Contact | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 | 16 Participants |
| Extended Health Education | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 | 13 Participants |
| Extended Relapse Prevention Plus Varenicline | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 | 16 Participants |
| Extended Relapse Prevention | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 104 | 13 Participants |
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.
Time frame: 64 weeks following treatment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Brief Contact | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 | 16 Participants |
| Extended Health Education | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 | 18 Participants |
| Extended Relapse Prevention Plus Varenicline | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 | 24 Participants |
| Extended Relapse Prevention | Number of Participants With Reported 7-day Point Prevalence Abstinence at Follow-up Week 64 | 13 Participants |
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.
Time frame: 12 weeks following treatment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Brief Contact | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 | 22 Participants |
| Extended Health Education | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 | 20 Participants |
| Extended Relapse Prevention Plus Varenicline | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 | 29 Participants |
| Extended Relapse Prevention | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 12 | 20 Participants |
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.
Time frame: 24 weeks following treatment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Brief Contact | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 | 20 Participants |
| Extended Health Education | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 | 18 Participants |
| Extended Relapse Prevention Plus Varenicline | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 | 24 Participants |
| Extended Relapse Prevention | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 24 | 21 Participants |
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.
Time frame: 52 weeks following treatment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Brief Contact | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 | 19 Participants |
| Extended Health Education | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 | 15 Participants |
| Extended Relapse Prevention Plus Varenicline | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 | 23 Participants |
| Extended Relapse Prevention | Number of Participants With Reported 7-day Point Prevalence Abstinence at Week 52 | 17 Participants |
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.
Time frame: 24 weeks following treatment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Brief Contact | Comparison of Combined Extended vs Brief Treatment at Week 24 | 20 Participants |
| Extended Health Education | Comparison of Combined Extended vs Brief Treatment at Week 24 | 63 Participants |
p-value: 0.62Chi-squared
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.
Time frame: 52 weeks following treatment initiation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Extended Brief Contact | Comparison of Combined Extended vs Brief Treatment at Week 52 | 19 Participants |
| Extended Health Education | Comparison of Combined Extended vs Brief Treatment at Week 52 | 55 Participants |
p-value: 0.91Chi-squared