Phase 3 N=538 Randomized Treatment

Smoking-Cessation and Stimulant Treatment (S-CAST)

Cocaine Dependence · Methamphetamine Dependence · Nicotine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01077024 ↗

Enrolled (actual)

538

Serious AEs

4.3%

Results posted

Aug 2014

Primary outcome: Primary: Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens — 77.7; 78.0 percentage of weeks

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Smoking-cessation treatment (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Cincinnati
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens	77.7; 78.0	—
SECONDARY Point-prevalence Abstinence (Smoking Outcome)	25.5; 2.2	—
SECONDARY Four Week Continuous Smoking Abstinence	6.7; 0.0	—
SECONDARY Stimulant-free Results at 3-month Visit	74.3; 68.8	—
SECONDARY Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit	19.1; 3.0	—
SECONDARY Stimulant-free Results at 6-month Visit	69.5; 71.6	—
SECONDARY Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit	13.1; 3.7	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01077024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.