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Trial record 99 of 2064 for:    Smoking Cessation

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

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ClinicalTrials.gov Identifier: NCT01077024
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cocaine Dependence
Methamphetamine Dependence
Nicotine Dependence
Intervention Other: Smoking-cessation treatment
Enrollment 538
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Smoking-cessation Treatment + Substance Treatment as Usual Substance-treatment as Usual
Hide 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
Reason Not Completed
Lost to Follow-up             20             14
Withdrawal by Subject             0             2
Incarcerated             7             8
Other             4             4
Arm/Group Title Smoking-cessation Treatment + Substance Treatment as Usual Substance-treatment as Usual Total
Hide 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 Number of Baseline Participants 267 271 538
Hide Baseline Analysis Population Description
The baseline analysis was performed on the Intent-to-Treat population, which was the population of randomized participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 271 participants 538 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
266
  99.6%
271
 100.0%
537
  99.8%
>=65 years
1
   0.4%
0
   0.0%
1
   0.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 271 participants 538 participants
Female
122
  45.7%
136
  50.2%
258
  48.0%
Male
145
  54.3%
135
  49.8%
280
  52.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 271 participants 538 participants
American Indian or Alaska Native
3
   1.1%
3
   1.1%
6
   1.1%
Asian
1
   0.4%
0
   0.0%
1
   0.2%
Native Hawaiian or Other Pacific Islander
0
   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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 267 participants 271 participants 538 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 267 participants 271 participants 538 participants
267 271 538
Weight  
Mean (Standard Deviation)
Unit of measure:  Pounds
Number Analyzed 267 participants 271 participants 538 participants
184.8  (43.77) 183.3  (44.21) 184.0  (43.96)
1.Primary Outcome
Title Stimulant-free Weeks Assessed by Self-report and Twice-weekly Urine Drug Screens
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smoking-cessation Treatment + Substance Treatment as Usual Substance-treatment as Usual
Hide 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.
Overall Number of Participants Analyzed 267 271
Measure Type: Number
Unit of Measure: percentage of weeks
77.7 78.0
2.Secondary Outcome
Title Point-prevalence Abstinence (Smoking Outcome)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smoking-cessation Treatment + Substance Treatment as Usual Substance-treatment as Usual
Hide 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.
Overall Number of Participants Analyzed 267 271
Measure Type: Number
Unit of Measure: percentage of participants
25.5 2.2
3.Secondary Outcome
Title Four Week Continuous Smoking Abstinence
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smoking-cessation Treatment + Substance Treatment as Usual Substance-treatment as Usual
Hide 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.
Overall Number of Participants Analyzed 267 271
Measure Type: Number
Unit of Measure: percentage of participants
6.7 0.0
4.Secondary Outcome
Title Stimulant-free Results at 3-month Visit
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 226 240
Measure Type: Number
Unit of Measure: percentage of participants
74.3 68.8
5.Secondary Outcome
Title Point-prevalence Abstinence (Smoking Outcome) 3 Month Visit
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smoking-cessation Treatment + Substance Treatment as Usual Substance-treatment as Usual
Hide 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.
Overall Number of Participants Analyzed 267 271
Measure Type: Number
Unit of Measure: percentage of participants
19.1 3.0
6.Secondary Outcome
Title Stimulant-free Results at 6-month Visit
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 210 218
Measure Type: Number
Unit of Measure: percentage of participants
69.5 71.6
7.Secondary Outcome
Title Point-prevalence Abstinence (Smoking Outcome) 6 Month Visit
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Smoking-cessation Treatment + Substance Treatment as Usual Substance-treatment as Usual
Hide 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.
Overall Number of Participants Analyzed 267 271
Measure Type: Number
Unit of Measure: percentage of participants
13.1 3.7
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide 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 (5.24%)      9/271 (3.32%)    
Cardiac disorders     
Angina Pectoris  1  0/267 (0.00%)  0 2/271 (0.74%)  2
Myocardial Infarction * 1  0/267 (0.00%)  0 1/271 (0.37%)  1
Eye disorders     
Vision blurred  1  1/267 (0.37%)  1 0/271 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain upper  1  0/267 (0.00%)  0 1/271 (0.37%)  1
Constiipation  1  0/267 (0.00%)  0 1/271 (0.37%)  1
Pancreatitis  1  0/267 (0.00%)  0 1/271 (0.37%)  1
General disorders     
Chest pain  1  1/267 (0.37%)  1 0/271 (0.00%)  0
Death * 1 [1]  1/267 (0.37%)  1 0/271 (0.00%)  0
Drug withdrawal syndrome * 1  1/267 (0.37%)  1 0/271 (0.00%)  0
Non-cardiac chest pain * 1  1/267 (0.37%)  1 0/271 (0.00%)  0
Infections and infestations     
Appendicitis  1  0/267 (0.00%)  0 1/271 (0.37%)  1
Pyelonephritis  1  1/267 (0.37%)  1 0/271 (0.00%)  0
Sepsis  1  1/267 (0.37%)  1 0/271 (0.00%)  0
Sinusitis  1  1/267 (0.37%)  1 0/271 (0.00%)  0
Injury, poisoning and procedural complications     
Tibia fracture  1  1/267 (0.37%)  1 0/271 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration  1  0/267 (0.00%)  0 1/271 (0.37%)  1
Musculoskeletal and connective tissue disorders     
Exostosis  1  1/267 (0.37%)  1 0/271 (0.00%)  0
Psychiatric disorders     
Depression  1  2/267 (0.75%)  2 0/271 (0.00%)  0
Panic Attack  1  1/267 (0.37%)  1 0/271 (0.00%)  0
Suicidal ideation  1  2/267 (0.75%)  2 1/271 (0.37%)  1
Suicide attempt * 1  0/267 (0.00%)  0 1/271 (0.37%)  1
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/267 (0.00%)  0 1/271 (0.37%)  1
Vascular disorders     
Haematoma  1  1/267 (0.37%)  1 0/271 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Death of unknown cause
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Smoking-cessation Treatment + Substance Treatment as Usual Substance-treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   181/267 (67.79%)      89/271 (32.84%)    
Gastrointestinal disorders     
Dry mouth  1  14/267 (5.24%)  14 0/271 (0.00%)  0
Nausea  1  18/267 (6.74%)  18 7/271 (2.58%)  7
Toothache  1  14/267 (5.24%)  14 15/271 (5.54%)  15
Infections and infestations     
Nasopharyngitis  1  19/267 (7.12%)  19 19/271 (7.01%)  19
Sinusitis  1  9/267 (3.37%)  9 14/271 (5.17%)  14
Upper respiratory tract infection  1  16/267 (5.99%)  16 13/271 (4.80%)  13
Nervous system disorders     
Headache  1  34/267 (12.73%)  34 13/271 (4.80%)  13
Psychiatric disorders     
Anxiety  1  20/267 (7.49%)  20 5/271 (1.85%)  5
Insomnia  1  21/267 (7.87%)  21 3/271 (1.11%)  3
Respiratory, thoracic and mediastinal disorders     
Throat irritation  1  16/267 (5.99%)  16 0/271 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Stimulant use was relatively low throughout the study; this may have limited our ability to make inferences about the treatment.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Theresa Winhusen
Organization: University of Cincinnati Addiction Sciences Division
Phone: 513-585-8227
EMail: winhust@ucmail.uc.edu
Layout table for additonal information
Responsible Party: University of Cincinnati
ClinicalTrials.gov Identifier: NCT01077024     History of Changes
Other Study ID Numbers: NIDA-CTN-0046
5U10DA013732 ( U.S. NIH Grant/Contract )
3U10DA013732-10 ( U.S. NIH Grant/Contract )
First Submitted: February 25, 2010
First Posted: February 26, 2010
Results First Submitted: April 24, 2014
Results First Posted: August 20, 2014
Last Update Posted: August 20, 2014