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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA009262-07 | U.S. NIH Grant/Contract | View source | |
| DPMC | Other Identifier | NIDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to identify subpopulations and baseline conditions that are most responsive to treatment for cocaine dependent individuals.
Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Motivational Interviewing (MI) is often effective when combined with drug treatment. Baseline condition (e.g., abstinence status) and population type (e.g., ethnicity and gender) often affect how an individual responds to treatment for drug dependence. The purpose of this study is to determine the influence of baseline status and population type on treatment response in cocaine dependent individuals. In addition, this study will examine how various cocaine abuse medications target different neuronal systems, withdrawal symptoms, and relapse to drug use.
This study will take place in two phases. Phase I will last 4 weeks; participants will receive MI and undergo contingency-based urine tests in order to achieve the desired baseline condition. Phase II will last 12 weeks. Participants in Phase II will be randomly assigned to receive one of four treatments: 1) 50 mg naltrexone, 2) 800/200 mg levodopa/carbidopa, 3) 400 mg modafinil, or 4) placebo. During Phase II, all participants will receive psychotherapy and contingency management. Participants will complete urine drug screening tests 3 times each week. Follow-up study visits will occur between 3 and 6 months following Week 12, and will include objective and self-reported drug use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil plus MI, CM, and CBT | Experimental | The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
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| Levodopa/Carbidopa plus MI, CM, and CBT | Experimental | Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
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| Naltrexone HCl plus MI, CM, and CBT | Experimental | Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase I. |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline | Cocaine use was determined by assessing for the presence of benzoylecgonine in urine. | 3 times per week (Monday, Wednesday, and Friday) for 12 weeks |
| Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline | Cocaine use was determined by assessing for the presence of benzoylecgonine in urine. | 3 times per week (Monday, Wednesday, and Friday) for 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy M Schmitz, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24424425 | Result | Schmitz JM, Green CE, Stotts AL, Lindsay JA, Rathnayaka NS, Grabowski J, Moeller FG. A two-phased screening paradigm for evaluating candidate medications for cocaine cessation or relapse prevention: modafinil, levodopa-carbidopa, naltrexone. Drug Alcohol Depend. 2014 Mar 1;136:100-7. doi: 10.1016/j.drugalcdep.2013.12.015. Epub 2014 Jan 3. |
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101 subjects were enrolled and began phase 1 (in phase 1, all enrolled subjects received the same intervention, motivational interviewing, which is described in the Interventions section). 81 completed phase 1, and 81 started phase 2, as described in the Period below. Subjects were assigned to the 4 arms at phase 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil Plus MI, CM, and CBT | The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo plus MI, CM, and CBT | Placebo Comparator | Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
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| Levodopa/Carbidopa | Drug | Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase I. |
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| Naltrexone HCl | Drug | Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase I. |
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| Placebo | Drug | Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance. |
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| Motivational Interviewing (MI) | Behavioral | The primary goal of motivational interviewing (MI) was to assist patients in achieving initial abstinence by increasing motivation and commitment to change. The MI intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. The client-centered, MI-style sessions focused on building motivation for change, exploring ambivalence, obtaining a commitment to change, making a plan for abstinence (Session 1), providing personalized feedback, reassessing commitment for change, and reevaluating the change plan (Session 2). Masters-level therapists were trained and supervised by the therapy supervisor (ALS), an expert in motivation-based therapies. |
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| Contingency management (CM) | Behavioral | Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during phase I) and medication compliance (during phase II). |
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| Cognitive-Behavioral Therapy (CBT) | Behavioral | Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. This therapy component focused on coping-skills training for resisting cocaine use in high-risk situations, based on relapse-prevention theory and manual-guided techniques. Therapy sessions were conducted by master's-level licensed professional counselors supervised by a licensed clinical psychologist, who monitored manual adherence and competency. |
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| FG001 | Levodopa/Carbidopa Plus MI, CM, and CBT | Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
| FG002 | Naltrexone HCl Plus MI, CM, and CBT | Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
| FG003 | Placebo Plus MI, CM, and CBT | Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
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| Received Drug or Placebo in Phase II |
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| COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil Plus MI, CM, and CBT | The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
| BG001 | Levodopa/Carbidopa Plus MI, CM, and CBT | Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
| BG002 | Naltrexone HCl Plus MI, CM, and CBT | Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
| BG003 | Placebo Plus MI, CM, and CBT | Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
| BG004 | 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup Achieving Abstinence at Baseline | Cocaine use was determined by assessing for the presence of benzoylecgonine in urine. | Posted | Mean | Standard Error | Mean % of cocaine-positive urines | 3 times per week (Monday, Wednesday, and Friday) for 12 weeks |
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| Primary | Mean Percentage of Cocaine-positive Urines Over Course of 12 Week Treatment in Subgroup NOT Achieving Abstinence at Baseline | Cocaine use was determined by assessing for the presence of benzoylecgonine in urine. | Posted | Mean | Standard Error | Mean % of cocaine-positive urines | 3 times per week (Monday, Wednesday, and Friday) for 12 weeks |
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The 12 weeks during which the drugs were administered (i.e., Phase II).
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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 | Modafinil Plus MI, CM, and CBT | The modafinil dose began at 200 mg (day 1) and increased to the fixed dose of 200 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. | 1 | 22 | 0 | 22 | ||
| EG001 | Levodopa/Carbidopa Plus MI, CM, and CBT | Levodopa-carbidopa, in the sustained-release formulation (Sinemet CR), began at a dose of levodopa/carbidopa 400/100 mg (day 1) and increased to the fixed dose of 400/100 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. | 4 | 25 | 0 | 25 | ||
| EG002 | Naltrexone HCl Plus MI, CM, and CBT | Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. | 1 | 16 | 0 | 16 | ||
| EG003 | Placebo Plus MI, CM, and CBT | Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. | 1 | 18 | 0 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| eye injury (torn conjunctiva) | Eye disorders | Systematic Assessment |
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| respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| arrhythmia symptoms | Cardiac disorders | Systematic Assessment |
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| suicidal tendencies | Psychiatric disorders | Systematic Assessment |
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| routine liver-function tests showed an increase from baseline in hepatic enzyme values | Hepatobiliary disorders | Systematic Assessment |
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| work-related traumatic injury to finger that required surgical repair | General disorders | Systematic Assessment |
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| deep vein thrombosis | Vascular disorders | Systematic Assessment |
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The sample size was small; however, the main aim of the study was achieved (i.e., to evaluate the feasibility of using a two-phase abstinence induction paradigm to screen candidate medications for cocaine treatment).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy M. Schmitz, PhD | The University of Texas Health Science Center at Houston | (713) 486-2867 | Joy.M.Schmitz@uth.tmc.edu |
| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| C009265 | carbidopa, levodopa drug combination |
| D009271 | Naltrexone |
| D062405 | Motivational Interviewing |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| Male |
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| OG002 | Naltrexone HCl Plus MI, CM, and CBT | Naltrexone hydrochloride (HCl) doses began at 25 mg (day 1) and increased to the fixed dose of 25 mg twice daily (day 2) during the 12 weeks of Phase II. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
| OG003 | Placebo Plus MI, CM, and CBT | Placebo capsules were identical in appearance to active drug capsules, and each contained 50 mg riboflavin for subsequent evaluation of medication compliance. The motivational interviewing (MI) intervention consisted of two 1-h individual therapy sessions on the first and eighth day of Phase I. Contingency management (CM) is a voucher-based intervention. Subjects earned vouchers for cocaine abstinence (during Phase I) and medication compliance (during Phase II). Subjects received weekly, 1-h, individual Cognitive-Behavioral Therapy (CBT) sessions during Phase II. |
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