Smoking-Cessation and Stimulant Treatment (S-CAST)

Nicotine Dependence Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077024
• Other study ID #: NIDA-CTN-0046
• Secondary ID: 5U10DA0137323U10
• Status: Completed
• Phase: Phase 3
• Start date: February 2010
• Est. completion date: August 2012

Study information

• Verified date: September 2021
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 538
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders
• Methamphetamine Dependence
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Gibson Recovery Center, Inc.	Cape Girardeau	Missouri
United States	Lexington/Richland Alcohol and Drug Abuse Council	Columbia	South Carolina
United States	Maryhaven	Columbus	Ohio
United States	Nexus Recovery Center	Dallas	Texas
United States	Gateway	Jacksonville	Florida
United States	Behavioral Health Services of Pickens County	Pickens	South Carolina
United States	Addiction Medicine Services	Pittsburgh	Pennsylvania
United States	Matrix Institute on Addictions	Rancho Cucamonga	California
United States	ADAPT	Roseburg	Oregon
United States	Dorchester	Summerville	South Carolina
United States	Tarzana Treatment Centers	Tarzana	California
United States	La Frontera	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Cincinnati	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 16
Secondary	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	Week 10 assessment
Secondary	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.	Post-quit days 15-42
Secondary	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.	3-month follow-up visit
Secondary	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	3- month follow-up visits
Secondary	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.	6 - months follow-up visit
Secondary	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	6 month visit

External Links

•   NIDA Clinical Trials Network