Smoking-Cessation and Stimulant Treatment (S-CAST)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01077024
First received: February 25, 2010
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Cocaine Dependence
Methamphetamine Dependence
Nicotine Dependence
Other: Smoking-cessation treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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:
  • Point-prevalence Abstinence (Smoking Outcome) [ Time Frame: Week 10 assessment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 538
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077024

Locations
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
Investigators
Principal Investigator: Theresa Winhusen, Ph.D. University of Cincinnati
  More Information

Additional Information:
No publications provided by University of Cincinnati

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT01077024     History of Changes
Other Study ID Numbers: NIDA-CTN-0046, 5U10DA013732, 3U10DA013732-10
Study First Received: February 25, 2010
Results First Received: April 24, 2014
Last Updated: July 31, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Cincinnati:
Stimulant treatment
Smoking Cessation

Additional relevant MeSH terms:
Tobacco Use Disorder
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014