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

Primary Purpose

Cocaine Dependence, Methamphetamine Dependence, Nicotine Dependence

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Smoking-cessation treatment
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Stimulant treatment, Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • La Frontera
  • Matrix Institute on Addictions
  • Tarzana Treatment Centers
  • Gateway
  • Gibson Recovery Center, Inc.
  • Maryhaven
  • ADAPT
  • Addiction Medicine Services
  • Lexington/Richland Alcohol and Drug Abuse Council
  • Behavioral Health Services of Pickens County
  • Dorchester
  • Nexus Recovery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Smoking-cessation treatment + substance treatment as usual

Substance-treatment as usual

Arm Description

Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.

Outcomes

Primary Outcome Measures

Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens
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)
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
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
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
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
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
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

Full Information

First Posted
February 25, 2010
Last Updated
September 27, 2021
Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01077024
Brief Title
Smoking-Cessation and Stimulant Treatment (S-CAST)
Acronym
S-CAST
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 Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence, Methamphetamine Dependence, Nicotine Dependence
Keywords
Stimulant treatment, Smoking Cessation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
538 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smoking-cessation treatment + substance treatment as usual
Arm Type
Experimental
Arm Title
Substance-treatment as usual
Arm Type
No Intervention
Arm Description
Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Intervention Type
Other
Intervention Name(s)
Smoking-cessation treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Point-prevalence Abstinence (Smoking Outcome)
Description
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
Time Frame
Week 10 assessment
Title
Four Week Continuous Smoking Abstinence
Description
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.
Time Frame
Post-quit days 15-42
Title
Stimulant-free Results at 3-month Visit
Description
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.
Time Frame
3-month follow-up visit
Title
Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit
Description
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
Time Frame
3- month follow-up visits
Title
Stimulant-free Results at 6-month Visit
Description
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.
Time Frame
6 - months follow-up visit
Title
Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit
Description
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
Time Frame
6 month visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Winhusen, Ph.D.
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
La Frontera
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85713
Country
United States
Facility Name
Matrix Institute on Addictions
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Tarzana Treatment Centers
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
Gateway
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32246
Country
United States
Facility Name
Gibson Recovery Center, Inc.
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Maryhaven
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
ADAPT
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97470
Country
United States
Facility Name
Addiction Medicine Services
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Lexington/Richland Alcohol and Drug Abuse Council
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Behavioral Health Services of Pickens County
City
Pickens
State/Province
South Carolina
ZIP/Postal Code
29671
Country
United States
Facility Name
Dorchester
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29483
Country
United States
Facility Name
Nexus Recovery Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75228
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30466549
Citation
Winhusen TM, Theobald J, Lewis DF. Substance use outcomes in cocaine-dependent tobacco smokers: A mediation analysis exploring the role of sleep disturbance, craving, anxiety, and depression. J Subst Abuse Treat. 2019 Jan;96:53-57. doi: 10.1016/j.jsat.2018.10.011. Epub 2018 Oct 26.
Results Reference
derived
PubMed Identifier
24345356
Citation
Winhusen TM, Brigham GS, Kropp F, Lindblad R, Gardin JG 2nd, Penn P, Hodgkins C, Kelly TM, Douaihy A, McCann M, Love LD, DeGravelles E, Bachrach K, Sonne SC, Hiott B, Haynes L, Sharma G, Lewis DF, VanVeldhuisen P, Theobald J, Ghitza U. A randomized trial of concurrent smoking-cessation and substance use disorder treatment in stimulant-dependent smokers. J Clin Psychiatry. 2014 Apr;75(4):336-43. doi: 10.4088/JCP.13m08449.
Results Reference
derived
PubMed Identifier
24128381
Citation
Winhusen TM, Kropp F, Theobald J, Lewis DF. Achieving smoking abstinence is associated with decreased cocaine use in cocaine-dependent patients receiving smoking-cessation treatment. Drug Alcohol Depend. 2014 Jan 1;134:391-395. doi: 10.1016/j.drugalcdep.2013.09.019. Epub 2013 Sep 27.
Results Reference
derived
PubMed Identifier
24075226
Citation
Winhusen TM, Adinoff B, Lewis DF, Brigham GS, Gardin JG 2nd, Sonne SC, Theobald J, Ghitza U. A tale of two stimulants: mentholated cigarettes may play a role in cocaine, but not methamphetamine, dependence. Drug Alcohol Depend. 2013 Dec 15;133(3):845-51. doi: 10.1016/j.drugalcdep.2013.09.002. Epub 2013 Sep 11.
Results Reference
derived
Links:
URL
http://www.drugabuse.gov/CTN/
Description
NIDA Clinical Trials Network

Learn more about this trial

Smoking-Cessation and Stimulant Treatment (S-CAST)

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