Clinical trial NCT01077024: Smoking-Cessation and Stimulant Treatment (S-CAST)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cocaine Dependence
Methamphetamine Dependence
Nicotine Dependence
Keywords: Stimulant treatment
Smoking Cessation
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-02-26
Enrollment: 538
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens
timeFrame: Week 16
Secondary outcomes:
measure: Point-prevalence Abstinence (Smoking Outcome)
timeFrame: Week 10 assessment
measure: Four Week Continuous Smoking Abstinence
timeFrame: Post-quit days 15-42
measure: Stimulant-free Results at 3-month Visit
timeFrame: 3-month follow-up visit
measure: Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit
timeFrame: 3- month follow-up visits
measure: Stimulant-free Results at 6-month Visit
timeFrame: 6 - months follow-up visit
measure: Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit
timeFrame: 6 month visit
Other outcomes:
Locations:
city: Tucson
country: United States
facility: La Frontera
state: Arizona
city: Rancho Cucamonga
country: United States
facility: Matrix Institute on Addictions
state: California
city: Tarzana
country: United States
facility: Tarzana Treatment Centers
state: California
city: Jacksonville
country: United States
facility: Gateway
state: Florida
city: Cape Girardeau
country: United States
facility: Gibson Recovery Center, Inc.
state: Missouri
city: Columbus
country: United States
facility: Maryhaven
state: Ohio
city: Roseburg
country: United States
facility: ADAPT
state: Oregon
city: Pittsburgh
country: United States
facility: Addiction Medicine Services
state: Pennsylvania
city: Columbia
country: United States
facility: Lexington/Richland Alcohol and Drug Abuse Council
state: South Carolina
city: Pickens
country: United States
facility: Behavioral Health Services of Pickens County
state: South Carolina
city: Summerville
country: United States
facility: Dorchester
state: South Carolina
city: Dallas
country: United States
facility: Nexus Recovery Center
state: Texas
Study officials:
affiliation: University of Cincinnati
name: Theresa Winhusen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.