Smoking-Cessation and Stimulant Treatment (S-CAST)

Phase 3

Completed

• Conditions: Cocaine Dependence; Methamphetamine Dependence; Nicotine Dependence
• Interventions: Other: Smoking-cessation treatment

• Registration Number: NCT01077024
• Lead Sponsor: University of Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Results First Submitted: 2014-04-24
• Results First Submitted QC: 2014-07-31
• Results First Posted: 2014-08-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 538

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoking-cessation treatment + substance treatment as usual	Smoking-cessation treatment	-

Primary Outcome Measures

Name	Time	Method
Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens	Week 16	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.

Secondary Outcome Measures

Name	Time	Method
Stimulant-free Results at 6-month Visit	6 - months follow-up visit	At the 6-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.
Point-prevalence Abstinence (Smoking Outcome)	Week 10 assessment	point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm
Four Week Continuous Smoking Abstinence	Post-quit days 15-42	A combination of daily self-reported smoking data and weekly carbon monoxide levels were used to determine continuous abstinence during post-quit days 15 - 42.
Stimulant-free Results at 3-month Visit	3-month follow-up visit	At the 3-month follow-up visit, percentage of participants with a negative urine drug screen for stimulant use and no stimulant use days reported during the past 28 days based on Timeline Follow-back.
Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit	3- month follow-up visits	point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm
Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit	6 month visit	point-prevalence abstinence defined as not smoking in the previous seven days based on self-report and confirmed with a Carbon Monoxide (CO) level ≤ 8 ppm

Trial Locations

Locations (12)

Matrix Institute on Addictions; 🇺🇸 Rancho Cucamonga, California, United States

La Frontera; 🇺🇸 Tucson, Arizona, United States

Tarzana Treatment Centers; 🇺🇸 Tarzana, California, United States

Gateway; 🇺🇸 Jacksonville, Florida, United States

Gibson Recovery Center, Inc.; 🇺🇸 Cape Girardeau, Missouri, United States

ADAPT; 🇺🇸 Roseburg, Oregon, United States

Behavioral Health Services of Pickens County; 🇺🇸 Pickens, South Carolina, United States

Dorchester; 🇺🇸 Summerville, South Carolina, United States

Maryhaven; 🇺🇸 Columbus, Ohio, United States

Addiction Medicine Services; 🇺🇸 Pittsburgh, Pennsylvania, United States

Lexington/Richland Alcohol and Drug Abuse Council; 🇺🇸 Columbia, South Carolina, United States

Nexus Recovery Center; 🇺🇸 Dallas, Texas, United States