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Smoking-Cessation and Stimulant Treatment (S-CAST) (S-CAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01077024
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : August 20, 2014
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Theresa Winhusen, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE February 25, 2010
First Posted Date  ICMJE February 26, 2010
Results First Submitted Date  ICMJE April 24, 2014
Results First Posted Date  ICMJE August 20, 2014
Last Update Posted Date September 29, 2021
Study Start Date  ICMJE February 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
Stimulant-free weeks assessed by self-report and twice-weekly urine drug screens [ Time Frame: Active treatment phsae ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2014)
  • Point-prevalence Abstinence (Smoking Outcome) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
  • Stimulant-free Results at 6-month Visit [ Time Frame: 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) 6 Month Visit [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2010)
  • Drug-free weeks assessed by self-report and twice-weekly urine drug screens [ Time Frame: Active Treatment Phase ]
  • Point-prevalence abstinence (smoking outcome) [ Time Frame: Week 10 assessment ]
  • Four week continuous smoking abstinence [ Time Frame: Post-quit days 15-42 ]
  • Stimulant-free urine drug screens [ Time Frame: 3- and 6-month follow-up visits ]
  • Drug-free urine drug screens [ Time Frame: 3- and 6-month follow-up visits ]
  • Point-prevalence abstinence (smoking outcome) [ Time Frame: 3- and 6-month follow-up visits ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smoking-Cessation and Stimulant Treatment (S-CAST)
Official Title  ICMJE Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cocaine Dependence
  • Methamphetamine Dependence
  • Nicotine Dependence
Intervention  ICMJE Other: Smoking-cessation treatment
Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
Study Arms  ICMJE
  • Experimental: Smoking-cessation treatment + substance treatment as usual
    Intervention: Other: Smoking-cessation treatment
  • No Intervention: Substance-treatment as usual
    Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 3, 2012)
538
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2010)
528
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01077024
Other Study ID Numbers  ICMJE NIDA-CTN-0046
5U10DA013732 ( U.S. NIH Grant/Contract )
3U10DA013732-10 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Theresa Winhusen, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Theresa Winhusen, Ph.D. University of Cincinnati
PRS Account University of Cincinnati
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP