MedPath

Smoking-Cessation and Stimulant Treatment (S-CAST)

Phase 3
Completed
Conditions
Cocaine Dependence
Methamphetamine Dependence
Nicotine Dependence
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

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
Primary Outcome Measures
NameTimeMethod
Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug ScreensWeek 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
NameTimeMethod
Stimulant-free Results at 6-month Visit6 - 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 AbstinencePost-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 Visit3-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 Visit3- 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 Visit6 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)

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

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La Frontera
🇺🇸Tucson, Arizona, United States

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