Smoking-Cessation and Stimulant Treatment (S-CAST) (S-CAST)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01077024 |
Recruitment Status :
Completed
First Posted : February 26, 2010
Results First Posted : August 20, 2014
Last Update Posted : September 29, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cocaine Dependence Methamphetamine Dependence Nicotine Dependence | Other: Smoking-cessation treatment | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 538 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Smoking-cessation treatment + substance treatment as usual |
Other: 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. |
No Intervention: Substance-treatment as usual
Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
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- Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens [ Time Frame: 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.
- Point-prevalence Abstinence (Smoking Outcome) [ Time Frame: 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
- Four Week Continuous Smoking Abstinence [ Time Frame: 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 [ Time Frame: 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) 3 Month Visit [ Time Frame: 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
- Stimulant-free Results at 6-month Visit [ Time Frame: 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 [ Time Frame: 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077024
United States, Arizona | |
La Frontera | |
Tucson, Arizona, United States, 85713 | |
United States, California | |
Matrix Institute on Addictions | |
Rancho Cucamonga, California, United States, 91730 | |
Tarzana Treatment Centers | |
Tarzana, California, United States, 91356 | |
United States, Florida | |
Gateway | |
Jacksonville, Florida, United States, 32246 | |
United States, Missouri | |
Gibson Recovery Center, Inc. | |
Cape Girardeau, Missouri, United States, 63703 | |
United States, Ohio | |
Maryhaven | |
Columbus, Ohio, United States, 43207 | |
United States, Oregon | |
ADAPT | |
Roseburg, Oregon, United States, 97470 | |
United States, Pennsylvania | |
Addiction Medicine Services | |
Pittsburgh, Pennsylvania, United States, 15213 | |
United States, South Carolina | |
Lexington/Richland Alcohol and Drug Abuse Council | |
Columbia, South Carolina, United States, 29204 | |
Behavioral Health Services of Pickens County | |
Pickens, South Carolina, United States, 29671 | |
Dorchester | |
Summerville, South Carolina, United States, 29483 | |
United States, Texas | |
Nexus Recovery Center | |
Dallas, Texas, United States, 75228 |
Principal Investigator: | Theresa Winhusen, Ph.D. | University of Cincinnati |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Theresa Winhusen, Professor; Director, Center for Addiction Research, University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT01077024 |
Other Study ID Numbers: |
NIDA-CTN-0046 5U10DA013732 ( U.S. NIH Grant/Contract ) 3U10DA013732-10 ( U.S. NIH Grant/Contract ) |
First Posted: | February 26, 2010 Key Record Dates |
Results First Posted: | August 20, 2014 |
Last Update Posted: | September 29, 2021 |
Last Verified: | September 2021 |
Stimulant treatment Smoking Cessation |
Tobacco Use Disorder Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |