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

September 27, 2021 updated by: Theresa Winhusen, University of Cincinnati

Smoking-Cessation and Stimulant Treatment (S-CAST): Evaluation of the Impact of Concurrent Outpatient Smoking-Cessation and Stimulant Treatment on Stimulant-Dependence Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

538

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85713
        • La Frontera
    • California
      • Rancho Cucamonga, California, United States, 91730
        • Matrix Institute on Addictions
      • Tarzana, California, United States, 91356
        • Tarzana Treatment Centers
    • Florida
      • Jacksonville, Florida, United States, 32246
        • Gateway
    • Missouri
      • Cape Girardeau, Missouri, United States, 63703
        • Gibson Recovery Center, Inc.
    • Ohio
      • Columbus, Ohio, United States, 43207
        • Maryhaven
    • Oregon
      • Roseburg, Oregon, United States, 97470
        • Adapt
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Addiction Medicine Services
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Lexington/Richland Alcohol and Drug Abuse Council
      • Pickens, South Carolina, United States, 29671
        • Behavioral Health Services of Pickens County
      • Summerville, South Carolina, United States, 29483
        • Dorchester
    • Texas
      • Dallas, Texas, United States, 75228
        • Nexus Recovery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 10 assessment
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.
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.
3-month follow-up visit
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
3- month follow-up visits
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 - months follow-up visit
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
6 month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Theresa Winhusen, Ph.D., University of Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

February 25, 2010

First Submitted That Met QC Criteria

February 25, 2010

First Posted (Estimate)

February 26, 2010

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CTN-0046
  • 5U10DA013732 (U.S. NIH Grant/Contract)
  • 3U10DA013732-10 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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