Cocaine Dependence, Methamphetamine Dependence, Nicotine Dependence
Conditions
Keywords
Stimulant treatment, Smoking Cessation
Brief summary
The primary objective of this study is to evaluate the impact of substance-abuse treatment as usual plus smoking-cessation treatment (TAU+SCT), relative to substance-abuse treatment as usual (TAU), on drug-abuse outcomes. Specifically, this study will evaluate whether concurrent smoking-cessation treatment improves, worsens, or has no effect on stimulant-use outcomes in smokers who are in outpatient substance-abuse treatment for cocaine or methamphetamine dependence.
Interventions
OTHERSmoking-cessation treatment
Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of cocaine/methamphetamine dependence * Smoked cigarettes for at least 3 months * Currently smoking \> 6 cigarettes/day * Have an interest in quitting smoking * Enrolled in outpatient treatment at a participating site
Exclusion criteria
* Clinical diagnosis of current alcohol or sedative dependence, bipolar disorder; or a life-time diagnosis of anorexia nervosa or bulimia * Seeking/receiving treatment for opiate-agonist replacement therapy * Medical conditions that could compromise participant safety * Taking medications with known/potential interactions with bupropion * Hypersensitivity to bupropion, nicotine, or menthol * Pregnant or breastfeeding * Abnormal ECG * Recent smoking cessation treatment * Use of tobacco products other than cigarettes in the past week * Likely to enter residential/inpatient treatment within 10 weeks * Have all stimulant-positive urine drug screens during screening/baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens | Week 16 | Stimulant-free week results (no cocaine, methamphetamine and amphetamine use) were obtained by combining the urine drug screens (UDS) and the self-reported Timeline Follow-Back (TLFB). At the group level, this outcome translates into the percentage of weeks in each study arm that are stimulant-free. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Four Week Continuous Smoking Abstinence | Post-quit days 15-42 | A combination of daily self-reported smoking data and weekly carbon monoxide levels were used to determine continuous abstinence during post-quit days 15 - 42. |
| Stimulant-free Results at 3-month Visit | 3-month follow-up visit | At the 3-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back. |
| Point-prevalence Abstinence (Smoking Outcome) | Week 10 assessment | point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm |
| Stimulant-free Results at 6-month Visit | 6 - months follow-up visit | At the 6-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back. |
| Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit | 6 month visit | point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm |
| Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit | 3- month follow-up visits | point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Smoking-cessation Treatment + Substance Treatment as Usual Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase. | 267 |
| Substance-treatment as Usual Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site. | 271 |
| Total | 538 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Incarcerated | 7 | 8 |
| Overall Study | Lost to Follow-up | 20 | 14 |
| Overall Study | Other | 4 | 4 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Smoking-cessation Treatment + Substance Treatment as Usual | Substance-treatment as Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 266 Participants | 271 Participants | 537 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 33 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 230 Participants | 236 Participants | 466 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 83 Participants | 88 Participants | 171 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 13 Participants | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 7 Participants | 21 Participants |
| Race (NIH/OMB) White | 162 Participants | 158 Participants | 320 Participants |
| Region of Enrollment United States | 267 participants | 271 participants | 538 participants |
| Sex: Female, Male Female | 122 Participants | 136 Participants | 258 Participants |
| Sex: Female, Male Male | 145 Participants | 135 Participants | 280 Participants |
| Weight | 184.8 pounds STANDARD_DEVIATION 43.77 | 183.3 pounds STANDARD_DEVIATION 44.21 | 184.0 pounds STANDARD_DEVIATION 43.96 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 181 / 267 | 89 / 271 |
| serious Total, serious adverse events | 14 / 267 | 9 / 271 |
Outcome results
Primary
Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens
Stimulant-free week results (no cocaine, methamphetamine and amphetamine use) were obtained by combining the urine drug screens (UDS) and the self-reported Timeline Follow-Back (TLFB). At the group level, this outcome translates into the percentage of weeks in each study arm that are stimulant-free.
Time frame: Week 16
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smoking-cessation Treatment + Substance Treatment as Usual | Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens | 77.7 percentage of weeks |
| Substance-treatment as Usual | Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens | 78.0 percentage of weeks |
Secondary
Four Week Continuous Smoking Abstinence
A combination of daily self-reported smoking data and weekly carbon monoxide levels were used to determine continuous abstinence during post-quit days 15 - 42.
Time frame: Post-quit days 15-42
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smoking-cessation Treatment + Substance Treatment as Usual | Four Week Continuous Smoking Abstinence | 6.7 percentage of participants |
| Substance-treatment as Usual | Four Week Continuous Smoking Abstinence | 0.0 percentage of participants |
Secondary
Point-prevalence Abstinence (Smoking Outcome)
point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm
Time frame: Week 10 assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smoking-cessation Treatment + Substance Treatment as Usual | Point-prevalence Abstinence (Smoking Outcome) | 25.5 percentage of participants |
| Substance-treatment as Usual | Point-prevalence Abstinence (Smoking Outcome) | 2.2 percentage of participants |
Secondary
Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit
point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm
Time frame: 3- month follow-up visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smoking-cessation Treatment + Substance Treatment as Usual | Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit | 19.1 percentage of participants |
| Substance-treatment as Usual | Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit | 3.0 percentage of participants |
Secondary
Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit
point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm
Time frame: 6 month visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smoking-cessation Treatment + Substance Treatment as Usual | Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit | 13.1 percentage of participants |
| Substance-treatment as Usual | Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit | 3.7 percentage of participants |
Secondary
Stimulant-free Results at 3-month Visit
At the 3-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.
Time frame: 3-month follow-up visit
Population: This outcome was only compared for participants who attended the 3-month follow-up visit (n=226 and n=240, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smoking-cessation Treatment + Substance Treatment as Usual | Stimulant-free Results at 3-month Visit | 74.3 percentage of participants |
| Substance-treatment as Usual | Stimulant-free Results at 3-month Visit | 68.8 percentage of participants |
Secondary
Stimulant-free Results at 6-month Visit
At the 6-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.
Time frame: 6 - months follow-up visit
Population: This outcome was only compared for participants who attended the 6-month follow-up visit (n=210 and n=218, respectively).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Smoking-cessation Treatment + Substance Treatment as Usual | Stimulant-free Results at 6-month Visit | 69.5 percentage of participants |
| Substance-treatment as Usual | Stimulant-free Results at 6-month Visit | 71.6 percentage of participants |