Smoking-Cessation and Stimulant Treatment (S-CAST)

Study Overview
=================
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.

Official Title
-----------------
Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes

Conditions
-----------------
Cocaine Dependence, Methamphetamine Dependence, Nicotine Dependence

Intervention / Treatment
-----------------
* Other: Smoking-cessation treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking-cessation treatment + substance treatment as usual<br> | Other: Smoking-cessation treatment<br>* 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.<br>|
| No Intervention: Substance-treatment as usual<br>Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 10 assessment | 
| 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. | Post-quit days 15-42 | 
| 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. | 3-month follow-up visit | 
| 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 | 3- month follow-up visits | 
| 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. | 6 - months follow-up visit | 
| 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 | 6 month visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stimulant treatment, Smoking Cessation