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| ID | Type | Description | Link |
|---|---|---|---|
| 5U10DA013732 | U.S. NIH Grant/Contract | View source | |
| 3U10DA013732-10 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smoking-cessation treatment + substance treatment as usual | Experimental |
| |
| Substance-treatment as usual | No Intervention | Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking-cessation treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Four Week Continuous Smoking Abstinence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Theresa Winhusen, Ph.D. | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Frontera | Tucson | Arizona | 85713 | United States | ||
| Matrix Institute on Addictions |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30466549 | Derived | 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. | |
| 24345356 | Derived | 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. |
| Label | URL |
|---|---|
| NIDA Clinical Trials Network | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Smoking-cessation Treatment + Substance Treatment as Usual | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | 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 | 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 | 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 | 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 |
| Rancho Cucamonga |
| California |
| 91730 |
| United States |
| Tarzana Treatment Centers | Tarzana | California | 91356 | United States |
| Gateway | Jacksonville | Florida | 32246 | United States |
| Gibson Recovery Center, Inc. | Cape Girardeau | Missouri | 63703 | United States |
| Maryhaven | Columbus | Ohio | 43207 | United States |
| ADAPT | Roseburg | Oregon | 97470 | United States |
| Addiction Medicine Services | Pittsburgh | Pennsylvania | 15213 | United States |
| Lexington/Richland Alcohol and Drug Abuse Council | Columbia | South Carolina | 29204 | United States |
| Behavioral Health Services of Pickens County | Pickens | South Carolina | 29671 | United States |
| Dorchester | Summerville | South Carolina | 29483 | United States |
| Nexus Recovery Center | Dallas | Texas | 75228 | United States |
| 24128381 | Derived | 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. |
| 24075226 | Derived | 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. |
| FG001 | Substance-treatment as Usual | Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site. |
| COMPLETED |
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| NOT COMPLETED |
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The baseline analysis was performed on the Intent-to-Treat population, which was the population of randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Smoking-cessation Treatment + Substance Treatment as Usual | 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. |
| BG001 | Substance-treatment as Usual | Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | pounds |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of weeks | 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 | Posted | Number | percentage of participants | 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. | Posted | Number | percentage of participants | 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. | This outcome was only compared for participants who attended the 3-month follow-up visit (n=226 and n=240, respectively). | Posted | Number | percentage of participants | 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 | Posted | Number | percentage of participants | 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. | This outcome was only compared for participants who attended the 6-month follow-up visit (n=210 and n=218, respectively). | Posted | Number | percentage of participants | 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 | Posted | Number | percentage of participants | 6 month visit |
|
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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.
Investigators systematically interviewed participants at each study week regarding any untoward events occurring since the last study visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smoking-cessation Treatment + Substance Treatment as Usual | 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. | 14 | 267 | 181 | 267 | ||
| EG001 | Substance-treatment as Usual | Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site. | 9 | 271 | 89 | 271 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Constiipation | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Death | General disorders | MedDRA (10.0) | Non-systematic Assessment | Death of unknown cause |
|
| Drug withdrawal syndrome | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
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| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Panic Attack | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
Stimulant use was relatively low throughout the study; this may have limited our ability to make inferences about the treatment.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Theresa Winhusen | University of Cincinnati Addiction Sciences Division | 513-585-8227 | winhust@ucmail.uc.edu |
| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D014029 | Tobacco Use Disorder |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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