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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA024652 | 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 purpose of this study is to evaluate the effects of 12 weeks of varenicline as compared to nicotine replacement therapy for smoking cessation among outpatients in treatment for substance use disorders. The intervention also incorporates counseling (Brief Advice), (adapted for sobriety settings), skills training and medication management.
People with substance use disorders (SUD) have a high prevalence and rate of smoking with little success in quitting, so stronger approaches are needed to encourage attempts to quit smoking. Brief advice (BA), to motivate cessation, produced some benefit but low abstinence rates for smokers with SUDs while adding free transdermal nicotine replacement therapy (NRT) improved short-term cessation rates. Varenicline has been found to produce higher rates of short and long-term abstinence than bupropion or placebo. However, a comparison between the efficacy of varenicline and NRT has not yet conducted with people with SUDs. Given the lack of effectiveness for standard smoking treatments for this population, what needs to be known is whether varenicline would increase the smoking abstinence rates relative to NRT when all receive motivational counseling.
The primary aim of this study is to evaluate the effects of 12 weeks of varenicline as compared to NRT, using a two-group randomized placebo-controlled design on smoking cessation rates for 12 months among 274 outpatients in treatment for SUD. The counseling incorporates BA (adapted slightly for sobriety settings by directly addressing barriers and concerns expressed by substance abusers), skills training and medication management. Confirmed point-prevalence and sustained abstinence will be assessed at 3 and 6 a months after the start of treatment. Secondary aims will examine potential mediators of effect including within-treatment abstinence, craving, and nicotine withdrawal levels.
The potential significance is to add to knowledge about the most effective ways to maximize smoking cessation among substance abusers, important given that no methods are known to work with this difficult population. No study published to date has compared varenicline to NRT for efficacy with patients with SUD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Replacement + PLA pill | Active Comparator | Nicotine replacement treatment patch plus matched placebo pill |
|
| Varenicline + PLA patch | Active Comparator | Varenicline plus matched placebo patches containing no nicotine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine Replacement Treatment (NRT) | Drug | Nicotine replacement treatment (NRT) will follow the clinical practice guidelines for nicotine patch for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use (tapering recommended for people with AUDs by Hughes et al., 2003b): 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 7-day Point-prevalence Smoking Abstinence | 7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. | 3 month follow up |
| 7-day Point-prevalence Smoking Abstinence | 7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. | 6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Longest Continuous Abstinence | Weeks 9 to 12 | |
| Percent Smoking Days | 3 month follow up | |
| Percent Smoking Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damaris J Rohsenow, Ph.D. | Brown University | Principal Investigator |
| Rosemarie Martin, Ph.D. | Brown University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University, Center for Alcohol and Addiction Studies | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18028247 | Background | Stapleton JA, Watson L, Spirling LI, Smith R, Milbrandt A, Ratcliffe M, Sutherland G. Varenicline in the routine treatment of tobacco dependence: a pre-post comparison with nicotine replacement therapy and an evaluation in those with mental illness. Addiction. 2008 Jan;103(1):146-54. doi: 10.1111/j.1360-0443.2007.02083.x. Epub 2007 Nov 19. | |
| 12500132 | Background | Rohsenow DJ, Monti PM, Colby SM, Martin RA. Brief interventions for smoking cessation in alcoholic smokers. Alcohol Clin Exp Res. 2002 Dec;26(12):1950-1. doi: 10.1097/01.ALC.0000041006.59547.9A. No abstract available. |
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Five individuals enrolled were found to not meet study criteria, 3 did not pass the medical screen, and 13 individuals were lost prior to being randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nicotine Replacement + PLA Pill | Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use: 21mg/day for 4 weeks, 14mg/day for 4 weeks, 7mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day. |
| FG001 | Varenicline + PLA Patch | Varenicline plus matched placebo patches containing no nicotine varenicline: Varenicline (VAR, 2mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nicotine Replacement + PLA Pill | Nicotine Replacement Treatment (NRT): Nicotine replacement treatment (NRT) will follow the clinical practice guidelines for nicotine patch for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use (tapering recommended for people with AUDs by Hughes et al., 2003b): 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 7-day Point-prevalence Smoking Abstinence | 7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. | "Intent to Treat" Note: People who were lost were counted as smoked | Posted | Number | participants | 3 month follow up |
|
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Structured interviews weekly for 12 weeks and at 3 & 6 months and as reported any time by participant or clinical staff member.
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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 | Nicotine Replacement + PLA Pill | Nicotine replacement treatment (NRT) patch plus matched placebo pill NRT will follow the clinical practice guidelines for people smoking at least 10 cigarettes per day (USDHHS, 2000), modified to allow 12 weeks use : 21 mg/day for 4 weeks, 14 mg/day for 4 weeks, 7 mg/day for 4 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| substance abuse (hospital or death) | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased depression | Psychiatric disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Damaris Rohsenow, PhD | Brown University | 401-863-6665 | Damaris_Rohsenow@brown.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| D000068580 | Varenicline |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
|
| varenicline | Drug | Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. |
|
|
| Behavioral counseling for smoking cessation | Behavioral | The counseling consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after Quit Day. |
|
|
| 6 month follow up |
| Percent Relapsed to Drug Use | 3 month follow up |
| Percent Relapsed to Drug Use | 6 month follow up |
| Percent Relapsed to Any Heavy Drinking | 6 or more drinks for men; 5 or more drinks for women | 3 month follow up |
| Percent Relapsed to Any Heavy Drinking | 6 or more drinks for men; 5 or more drinks for women | 6 month follow up |
| Beck Depression Inventory | 0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression | Week 12 |
| 28498504 | Result | Rohsenow DJ, Tidey JW, Martin RA, Colby SM, Swift RM, Leggio L, Monti PM. Varenicline versus nicotine patch with brief advice for smokers with substance use disorders with or without depression: effects on smoking, substance use and depressive symptoms. Addiction. 2017 Oct;112(10):1808-1820. doi: 10.1111/add.13861. Epub 2017 Jul 4. |
| 28500373 | Result | Murphy CM, MacKillop J, Martin RA, Tidey JW, Colby SM, Rohsenow DJ. Effects of varenicline versus transdermal nicotine replacement therapy on cigarette demand on quit day in individuals with substance use disorders. Psychopharmacology (Berl). 2017 Aug;234(16):2443-2452. doi: 10.1007/s00213-017-4635-4. Epub 2017 May 13. |
| BG001 | Varenicline + PLA Patch | varenicline: Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after Quit Day. Pl |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Varenicline + PLA Patch | Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day. |
|
|
|
| Secondary | Length of Longest Continuous Abstinence | Posted | Mean | Standard Deviation | Days | Weeks 9 to 12 |
|
|
|
|
| Primary | 7-day Point-prevalence Smoking Abstinence | 7 -day smoking cessation confirmed by expired alveolar CO levels of < 10 ppm or salivary cotinine < 16 ng/ml. | Posted | Number | participants | 6 month follow up |
|
|
|
|
| Secondary | Percent Smoking Days | Outcome data available for 89 participants who completed 3 month follow up. | Posted | Mean | Standard Deviation | percentage of days | 3 month follow up |
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|
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| Secondary | Percent Smoking Days | Outcome data available for 80 participants who completed 6 month follow up. | Posted | Mean | Standard Deviation | percentage of days | 6 month follow up |
|
|
|
|
| Secondary | Percent Relapsed to Drug Use | Outcome data available for 89 participants who completed 3 month follow up. | Posted | Number | percentage of participants | 3 month follow up |
|
|
|
|
| Secondary | Percent Relapsed to Drug Use | Outcome data available for 80 participants who completed 6 month follow up. | Posted | Number | percentage of participants | 6 month follow up |
|
|
|
|
| Secondary | Percent Relapsed to Any Heavy Drinking | 6 or more drinks for men; 5 or more drinks for women | Outcome data available for 89 participants who completed 3 month follow up. | Posted | Number | percentage of participants | 3 month follow up |
|
|
|
|
| Secondary | Percent Relapsed to Any Heavy Drinking | 6 or more drinks for men; 5 or more drinks for women | Outcome data available for 80 participants who completed 6 month follow up. | Posted | Number | percentage of particpiants | 6 month follow up |
|
|
|
|
| Secondary | Beck Depression Inventory | 0-10 = These ups and downs are considered normal 11-16 = Mild mood disturbance 17-20 = Borderline clinical depression 21-30 = Moderate depression 31-40 = Severe depression over 40 = Extreme depression | Outcome data available for 80 participants who had valid depression data 12 week assessment. | Posted | Mean | Standard Deviation | units on a scale | Week 12 |
|
|
|
|
| 3 |
| 60 |
| 3 |
| 60 |
| EG001 | Varenicline + PLA Patch | Varenicline plus matched placebo patches containing no nicotine Varenicline (VAR, 2 mg/d in divided doses) will be administered as follows. VAR: participant takes 0.5 mg/d for the first 3 days, 1 mg/d (0.5 mg 2x/d) for the next 4 days, and 2mg/d (1.0mg 2x/d) for 12 weeks. Behavioral counseling for smoking cessation consists of 10 sessions of Brief Advice (BA).BA is a simple smoking cessation counseling strategy: Assess smoking and initial interest in cessation, advise patient to quit smoking, assist patient in quitting, discussion of sobriety specific concerns, and cognitive-behavioral skills training. Medication management is conducted in every session, smoking cessation pamphlets are available. Session 1 (60 min, in-person) will be 1 week before Quit Day.Session 2 (30 min, in-person) takes place on Quit Day. Session 3 (10 min, in-person) will be 1 week later. Sessions 4-10 will be 5-10 min. telephone contacts at Weeks 2, 3, 4, 6, 8, 10, and 12 after quit day. | 10 | 77 | 1 | 77 |
| accidents (ER or hospital) | Musculoskeletal and connective tissue disorders |
|
| hospital and respiratory disorder | Respiratory, thoracic and mediastinal disorders |
|
| pregnancy complication | Reproductive system and breast disorders |
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| diabetic complication | Endocrine disorders |
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| disorientation | Nervous system disorders |
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| D001523 |
| Mental Disorders |
| D012907 | Smoking |
| D064424 | Tobacco Use |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |