Smoking-Cessation and Stimulant Treatment (S-CAST)
S-CAST
3 other identifiers
interventional
538
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2010
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 25, 2010
CompletedFirst Posted
Study publicly available on registry
February 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
August 20, 2014
CompletedSeptember 29, 2021
September 1, 2021
2.5 years
February 25, 2010
April 24, 2014
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Point-prevalence Abstinence (Smoking Outcome)
Week 10 assessment
Four Week Continuous Smoking Abstinence
Post-quit days 15-42
Stimulant-free Results at 3-month Visit
3-month follow-up visit
Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit
3- month follow-up visits
Stimulant-free Results at 6-month Visit
6 - months follow-up visit
- +1 more secondary outcomes
Study Arms (2)
Smoking-cessation treatment + substance treatment as usual
EXPERIMENTALSubstance-treatment as usual
NO INTERVENTIONTreatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- National Institute on Drug Abuse (NIDA)collaborator
Study Sites (12)
La Frontera
Tucson, Arizona, 85713, United States
Matrix Institute on Addictions
Rancho Cucamonga, California, 91730, United States
Tarzana Treatment Centers
Tarzana, California, 91356, United States
Gateway
Jacksonville, Florida, 32246, United States
Gibson Recovery Center, Inc.
Cape Girardeau, Missouri, 63703, United States
Maryhaven
Columbus, Ohio, 43207, United States
ADAPT
Roseburg, Oregon, 97470, United States
Addiction Medicine Services
Pittsburgh, Pennsylvania, 15213, United States
Lexington/Richland Alcohol and Drug Abuse Council
Columbia, South Carolina, 29204, United States
Behavioral Health Services of Pickens County
Pickens, South Carolina, 29671, United States
Dorchester
Summerville, South Carolina, 29483, United States
Nexus Recovery Center
Dallas, Texas, 75228, United States
Related Publications (4)
Winhusen TM, Theobald J, Lewis DF. Substance use outcomes in cocaine-dependent tobacco smokers: A mediation analysis exploring the role of sleep disturbance, craving, anxiety, and depression. J Subst Abuse Treat. 2019 Jan;96:53-57. doi: 10.1016/j.jsat.2018.10.011. Epub 2018 Oct 26.
PMID: 30466549DERIVEDWinhusen TM, Brigham GS, Kropp F, Lindblad R, Gardin JG 2nd, Penn P, Hodgkins C, Kelly TM, Douaihy A, McCann M, Love LD, DeGravelles E, Bachrach K, Sonne SC, Hiott B, Haynes L, Sharma G, Lewis DF, VanVeldhuisen P, Theobald J, Ghitza U. A randomized trial of concurrent smoking-cessation and substance use disorder treatment in stimulant-dependent smokers. J Clin Psychiatry. 2014 Apr;75(4):336-43. doi: 10.4088/JCP.13m08449.
PMID: 24345356DERIVEDWinhusen TM, Kropp F, Theobald J, Lewis DF. Achieving smoking abstinence is associated with decreased cocaine use in cocaine-dependent patients receiving smoking-cessation treatment. Drug Alcohol Depend. 2014 Jan 1;134:391-395. doi: 10.1016/j.drugalcdep.2013.09.019. Epub 2013 Sep 27.
PMID: 24128381DERIVEDWinhusen TM, Adinoff B, Lewis DF, Brigham GS, Gardin JG 2nd, Sonne SC, Theobald J, Ghitza U. A tale of two stimulants: mentholated cigarettes may play a role in cocaine, but not methamphetamine, dependence. Drug Alcohol Depend. 2013 Dec 15;133(3):845-51. doi: 10.1016/j.drugalcdep.2013.09.002. Epub 2013 Sep 11.
PMID: 24075226DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Stimulant use was relatively low throughout the study; this may have limited our ability to make inferences about the treatment.
Results Point of Contact
- Title
- Dr. Theresa Winhusen
- Organization
- University of Cincinnati Addiction Sciences Division
Study Officials
- PRINCIPAL INVESTIGATOR
Theresa Winhusen, Ph.D.
University of Cincinnati
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor; Director, Center for Addiction Research
Study Record Dates
First Submitted
February 25, 2010
First Posted
February 26, 2010
Study Start
February 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
September 29, 2021
Results First Posted
August 20, 2014
Record last verified: 2021-09