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

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ClinicalTrials.gov Identifier: NCT01077024
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Cincinnati

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Methamphetamine Dependence Nicotine Dependence Other: Smoking-cessation treatment Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 538 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes
Study Start Date : February 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Smoking-cessation treatment + substance treatment as usual 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.
No Intervention: Substance-treatment as usual
Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077024


Locations
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United States, Arizona
La Frontera
Tucson, Arizona, United States, 85713
United States, California
Matrix Institute on Addictions
Rancho Cucamonga, California, United States, 91730
Tarzana Treatment Centers
Tarzana, California, United States, 91356
United States, Florida
Gateway
Jacksonville, Florida, United States, 32246
United States, Missouri
Gibson Recovery Center, Inc.
Cape Girardeau, Missouri, United States, 63703
United States, Ohio
Maryhaven
Columbus, Ohio, United States, 43207
United States, Oregon
ADAPT
Roseburg, Oregon, United States, 97470
United States, Pennsylvania
Addiction Medicine Services
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Lexington/Richland Alcohol and Drug Abuse Council
Columbia, South Carolina, United States, 29204
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States, 29671
Dorchester
Summerville, South Carolina, United States, 29483
United States, Texas
Nexus Recovery Center
Dallas, Texas, United States, 75228
Sponsors and Collaborators
University of Cincinnati
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Theresa Winhusen, Ph.D. University of Cincinnati
More Information
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Additional Information:
NIDA Clinical Trials Network  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT01077024     History of Changes
Other Study ID Numbers: NIDA-CTN-0046
5U10DA013732 ( U.S. NIH Grant/Contract )
3U10DA013732-10 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2010    Key Record Dates
Results First Posted: August 20, 2014
Last Update Posted: August 20, 2014
Last Verified: July 2014
Keywords provided by University of Cincinnati:
Stimulant treatment
Smoking Cessation
Additional relevant MeSH terms:
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Tobacco Use Disorder
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
 Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs