Smoking-Cessation and Stimulant Treatment (S-CAST)

• Sponsor: University of Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT01077024
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 538
• Locations: 12
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 44.8
• Patients Per Site Per Month: 1.5

Study Details

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.

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

Study Design

• Study Type: Interventional
• 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: Feb 1, 2010
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

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

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	La Frontera	Tucson	Arizona	United States	85713
2	Matrix Institute on Addictions	Rancho Cucamonga	California	United States	91730
3	Tarzana Treatment Centers	Tarzana	California	United States	91356
4	Gateway	Jacksonville	Florida	United States	32246
5	Gibson Recovery Center, Inc.	Cape Girardeau	Missouri	United States	63703
6	Maryhaven	Columbus	Ohio	United States	43207
7	ADAPT	Roseburg	Oregon	United States	97470
8	Addiction Medicine Services	Pittsburgh	Pennsylvania	United States	15213
9	Lexington/Richland Alcohol and Drug Abuse Council	Columbia	South Carolina	United States	29204
10	Behavioral Health Services of Pickens County	Pickens	South Carolina	United States	29671
11	Dorchester	Summerville	South Carolina	United States	29483
12	Nexus Recovery Center	Dallas	Texas	United States	75228

Sponsors and Collaborators

• University of Cincinnati
• National Institute on Drug Abuse (NIDA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NIDA Clinical Trials Network

Publications

None provided.

• Responsible Party: Theresa Winhusen, Professor; Director, Center for Addiction Research, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT01077024
• Other Study ID Numbers: NIDA-CTN-0046; 5U10DA013732; 3U10DA013732-10
• First Posted: Feb 26, 2010
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Theresa Winhusen, Professor; Director, Center for Addiction Research, University of Cincinnati: Stimulant treatment; Smoking Cessation
• Additional relevant MeSH terms: Tobacco Use Disorder; Cocaine-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual	Substance-treatment as Usual
Arm/Group Description	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.	Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Period Title: Overall Study
STARTED	267	271
COMPLETED	236	243
NOT COMPLETED	31	28

Baseline Characteristics

Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual	Substance-treatment as Usual	Total
Arm/Group Description	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.	Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.	Total of all reporting groups
Overall Participants	267	271	538
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	266 99.6%	271 100%	537 99.8%
>=65 years	1 0.4%	0 0%	1 0.2%
Sex: Female, Male (Count of Participants)
Female	122 45.7%	136 50.2%	258 48%
Male	145 54.3%	135 49.8%	280 52%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 1.1%	3 1.1%	6 1.1%
Asian	1 0.4%	0 0%	1 0.2%
Native Hawaiian or Other Pacific Islander	0 0%	2 0.7%	2 0.4%
Black or African American	83 31.1%	88 32.5%	171 31.8%
White	162 60.7%	158 58.3%	320 59.5%
More than one race	4 1.5%	13 4.8%	17 3.2%
Unknown or Not Reported	14 5.2%	7 2.6%	21 3.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	34 12.7%	33 12.2%	67 12.5%
Not Hispanic or Latino	230 86.1%	236 87.1%	466 86.6%
Unknown or Not Reported	3 1.1%	2 0.7%	5 0.9%
Region of Enrollment (participants) [Number]
United States	267 100%	271 100%	538 100%
Weight (pounds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [pounds]	184.8 (43.77)	183.3 (44.21)	184.0 (43.96)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual	Substance-treatment as Usual
Arm/Group Description	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.	Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Measure Participants	267	271
Number [percentage of weeks]	77.7	78.0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual	Substance-treatment as Usual
Arm/Group Description	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.	Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Measure Participants	267	271
Number [percentage of participants]	25.5 9.6%	2.2 0.8%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual	Substance-treatment as Usual
Arm/Group Description	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.	Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Measure Participants	267	271
Number [percentage of participants]	6.7 2.5%	0.0 0%

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This outcome was only compared for participants who attended the 3-month follow-up visit (n=226 and n=240, respectively).

Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual	Substance-treatment as Usual
Arm/Group Description	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.	Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Measure Participants	226	240
Number [percentage of participants]	74.3 27.8%	68.8 25.4%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual	Substance-treatment as Usual
Arm/Group Description	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.	Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Measure Participants	267	271
Number [percentage of participants]	19.1 7.2%	3.0 1.1%

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This outcome was only compared for participants who attended the 6-month follow-up visit (n=210 and n=218, respectively).

Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual	Substance-treatment as Usual
Arm/Group Description	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.	Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Measure Participants	210	218
Number [percentage of participants]	69.5 26%	71.6 26.4%

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual	Substance-treatment as Usual
Arm/Group Description	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.	Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
Measure Participants	267	271
Number [percentage of participants]	13.1 4.9%	3.7 1.4%

Adverse Events

Time Frame	A systematic collection of adverse events occurred from the time of consent to the 10th week final visit. Serious adverse events discovered unsystematically were collected through 30 days following the 10th week final visit.
Adverse Event Reporting Description	Investigators systematically interviewed participants at each study week regarding any untoward events occurring since the last study visit.
Arm/Group Title	Smoking-cessation Treatment + Substance Treatment as Usual		Substance-treatment as Usual
Arm/Group Description	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.		Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
All Cause Mortality
	Smoking-cessation Treatment + Substance Treatment as Usual		Substance-treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Smoking-cessation Treatment + Substance Treatment as Usual		Substance-treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/267 (5.2%)		9/271 (3.3%)
Cardiac disorders
Angina Pectoris	0/267 (0%)	0	2/271 (0.7%)	2
Myocardial Infarction	0/267 (0%)	0	1/271 (0.4%)	1
Eye disorders
Vision blurred	1/267 (0.4%)	1	0/271 (0%)	0
Gastrointestinal disorders
Abdominal pain upper	0/267 (0%)	0	1/271 (0.4%)	1
Constiipation	0/267 (0%)	0	1/271 (0.4%)	1
Pancreatitis	0/267 (0%)	0	1/271 (0.4%)	1
General disorders
Chest pain	1/267 (0.4%)	1	0/271 (0%)	0
Death	1/267 (0.4%)	1	0/271 (0%)	0
Drug withdrawal syndrome	1/267 (0.4%)	1	0/271 (0%)	0
Non-cardiac chest pain	1/267 (0.4%)	1	0/271 (0%)	0
Infections and infestations
Appendicitis	0/267 (0%)	0	1/271 (0.4%)	1
Pyelonephritis	1/267 (0.4%)	1	0/271 (0%)	0
Sepsis	1/267 (0.4%)	1	0/271 (0%)	0
Sinusitis	1/267 (0.4%)	1	0/271 (0%)	0
Injury, poisoning and procedural complications
Tibia fracture	1/267 (0.4%)	1	0/271 (0%)	0
Metabolism and nutrition disorders
Dehydration	0/267 (0%)	0	1/271 (0.4%)	1
Musculoskeletal and connective tissue disorders
Exostosis	1/267 (0.4%)	1	0/271 (0%)	0
Psychiatric disorders
Depression	2/267 (0.7%)	2	0/271 (0%)	0
Panic Attack	1/267 (0.4%)	1	0/271 (0%)	0
Suicidal ideation	2/267 (0.7%)	2	1/271 (0.4%)	1
Suicide attempt	0/267 (0%)	0	1/271 (0.4%)	1
Respiratory, thoracic and mediastinal disorders
Asthma	0/267 (0%)	0	1/271 (0.4%)	1
Vascular disorders
Haematoma	1/267 (0.4%)	1	0/271 (0%)	0
Other (Not Including Serious) Adverse Events
	Smoking-cessation Treatment + Substance Treatment as Usual		Substance-treatment as Usual
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	181/267 (67.8%)		89/271 (32.8%)
Gastrointestinal disorders
Dry mouth	14/267 (5.2%)	14	0/271 (0%)	0
Nausea	18/267 (6.7%)	18	7/271 (2.6%)	7
Toothache	14/267 (5.2%)	14	15/271 (5.5%)	15
Infections and infestations
Nasopharyngitis	19/267 (7.1%)	19	19/271 (7%)	19
Sinusitis	9/267 (3.4%)	9	14/271 (5.2%)	14
Upper respiratory tract infection	16/267 (6%)	16	13/271 (4.8%)	13
Nervous system disorders
Headache	34/267 (12.7%)	34	13/271 (4.8%)	13
Psychiatric disorders
Anxiety	20/267 (7.5%)	20	5/271 (1.8%)	5
Insomnia	21/267 (7.9%)	21	3/271 (1.1%)	3
Respiratory, thoracic and mediastinal disorders
Throat irritation	16/267 (6%)	16	0/271 (0%)	0

Limitations/Caveats

Stimulant use was relatively low throughout the study; this may have limited our ability to make inferences about the treatment.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.