Smoking-Cessation and Stimulant Treatment (S-CAST)
This study has been completed.
Sponsor:
University of Cincinnati
Collaborator:
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01077024
First received: February 25, 2010
Last updated: October 3, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cocaine Dependence Methamphetamine Dependence Nicotine Dependence |
Other: Smoking-cessation treatment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University of Cincinnati:
Primary Outcome Measures:
- Stimulant-free weeks assessed by self-report and twice-weekly urine drug screens [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Drug-free weeks assessed by self-report and twice-weekly urine drug screens [ Time Frame: Study Week 16 ] [ Designated as safety issue: No ]
- Point-prevalence abstinence (smoking outcome) [ Time Frame: Week 10 assessment ] [ Designated as safety issue: No ]
- Four week continuous smoking abstinence [ Time Frame: Post-quit days 15-42 ] [ Designated as safety issue: No ]
- Stimulant-free urine drug screens [ Time Frame: 3- and 6-month follow-up visits ] [ Designated as safety issue: No ]
- Drug-free urine drug screens [ Time Frame: 3- and 6-month follow-up visits ] [ Designated as safety issue: No ]
- Point-prevalence abstinence (smoking outcome) [ Time Frame: 3- and 6-month follow-up visits ] [ Designated as safety issue: No ]
| Enrollment: | 538 |
| Study Start Date: | February 2010 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01077024
Locations
| 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 | |
Sponsors and Collaborators
University of Cincinnati
Investigators
| Principal Investigator: | Theresa Winhusen, Ph.D. | University of Cincinnati |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01077024 History of Changes |
| Other Study ID Numbers: | NIDA-CTN-0046, 5U10DA013732, 3U10DA013732-10 |
| Study First Received: | February 25, 2010 |
| Last Updated: | October 3, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Cincinnati:
|
Stimulant treatment Smoking Cessation |
Additional relevant MeSH terms:
|
Tobacco Use Disorder Smoking Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Habits |
Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013