Smoking-Cessation and Stimulant Treatment (S-CAST)

University of Cincinnati

Status and phase: Completed; Phase 3

Conditions: Methamphetamine Dependence; Nicotine Dependence; Cocaine Dependence

Treatments: Other: Smoking-cessation treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01077024

3U10DA013732-10 (U.S. NIH Grant/Contract)

5U10DA013732 (U.S. NIH Grant/Contract)

NIDA-CTN-0046

Details and patient eligibility

About

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.

Enrollment: 538 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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538 participants in 2 patient groups

Smoking-cessation treatment + substance treatment as usual

Experimental group

Treatment:

Other: Smoking-cessation treatment

Substance-treatment as usual

No Intervention group

Description:

Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.