Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
538 participants
INTERVENTIONAL
2010-02-28
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Substance-treatment as usual
Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
University of Cincinnati
OTHER
Responsible Party
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Theresa Winhusen
Professor; Director, Center for Addiction Research
Principal Investigators
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Theresa Winhusen, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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La Frontera
Tucson, Arizona, United States
Matrix Institute on Addictions
Rancho Cucamonga, California, United States
Tarzana Treatment Centers
Tarzana, California, United States
Gateway
Jacksonville, Florida, United States
Gibson Recovery Center, Inc.
Cape Girardeau, Missouri, United States
Maryhaven
Columbus, Ohio, United States
ADAPT
Roseburg, Oregon, United States
Addiction Medicine Services
Pittsburgh, Pennsylvania, United States
Lexington/Richland Alcohol and Drug Abuse Council
Columbia, South Carolina, United States
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States
Dorchester
Summerville, South Carolina, United States
Nexus Recovery Center
Dallas, Texas, United States
Countries
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References
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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.
Winhusen 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.
Winhusen 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.
Winhusen 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.
Related Links
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NIDA Clinical Trials Network
Other Identifiers
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