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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA021264 | 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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The purpose of this study is to compare the efficacy of the combined treatment modafinil + Contingency Management (CM) to either treatment condition alone or to yoked-controls on cocaine abstinence.
To investigate the role of modafinil-related improvements in memory, impulse control, and attention in mediating cocaine abstinence.
We hypothesize that the treatment group receiving the combination of modafinil + Contingency Management will have significantly lower cocaine use than the other treatment conditions. We also hypothesize that improvements in memory, impulse control, and attention will be a significant contributor to the treatment improvements investigated in Specific Aim #1.
Opioid and cocaine dependence are major problems among veteran and non-veterans and no effective pharmacotherapy exists for cocaine dependence. Methadone has not shown robust effectiveness in reducing cocaine abuse. Thus, new treatments are needed for the individuals who have developed cocaine dependence. This study is designed to test a new pharmacotherapy for cocaine dependence and is a placebo-controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil Plus Contingency Magagement | Active Comparator | Modafinil from 200mg up to 400mg plus Contingency Management |
|
| Sugar Pill Plus Contingency Management | Placebo Comparator | Placebo: sugar pill |
|
| Modafinil Plus Voucher Control | Active Comparator |
| |
| Sugar Pill Plus Voucher Control | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Positive Urine Tests | thrice weekly urine tests | up to 12 weeks. |
| Average Maximum Days Abstinent | up to 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Days Using a Substance Within Treatment | up to 90 days |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Sofuoglu, M.D.,Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Veterans Affairs | West Haven | Connecticut | 06516 | United States |
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After eligibility was determined, participants were randomized to placebo, 200mg up to 400mg of modafinil.The study consisted of three phases that involve: 1) a one or two week "induction" phase, 2) an eleven-week "treatment" phase; and 3) a four week "taper, detoxification or transfer" phase.
Adult male and female participants were recruited from the Greater New Haven area from May 2008 to March 2014 by word-of-mouth, flyers and from referrals from treatment centers in the local area. The study was conducted in an outpatient clinic of the West Haven VA Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil Plus Contingency Management | Modafinil from 200mg up to 400mg Modafinil: Modafinil will be phase in from 200mg to 400mg |
| FG001 | Modafinil Plus Voucher Control | Modafinil from 200mg up to 400mg plus the voucher control |
| FG002 | Placebo Plus Voucher Control | Sugar pill plus voucher control |
| FG003 | Placebo Plus Contingency Management | Sugar pill plus contingency management |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Week 1 Days 1-3 |
| |||||||||||||
| Day 4 to Week 11 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil Plus CM | Modafinil from 200mg up to 400mg Modafinil: Modafinil will be phase in from 200mg to 400mg |
| BG001 | Modafinil Plus Voucher Control | Modafinil from 200mg up to 400mg Modafinil: Modafinil will be phase in from 200mg to 400mg |
| 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 | Average Number of Positive Urine Tests | thrice weekly urine tests | Posted | Mean | Standard Deviation | urine tests | up to 12 weeks. |
|
12 weeks
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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 Contingency Magagement | Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study. Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disturbed concentration | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Sofuoglu, M.D.,Ph.D. | Yale University | 203-937-4809 | mehmet.sofuoglu@yale.edu |
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| 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 |
| D000073893 | Sugars |
| D008691 | Methadone |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Sugar Pill | Drug | placebo, sugar pill will mirror active drug |
|
|
| Contingency Management | Behavioral | Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample. |
|
| Methadone | Drug | Subjects will be started on 30 mg of methadone and the dose will be increased as tolerated to reach 60 mg at the end of the first 1-2 weeks of the induction phase. Methadone dosing will bestabilized. During methadone maintenance (weeks 1-11 of treatment phase), subjects continue to receive their maintenance doses of methadone plus modafinil or placebo. |
|
| cognitive behavioral treatment | Behavioral | All subjects will receive a manual-guided CBT treatment over the course of their 16-week participation. This manual-guided therapy promotes abstinence through a functional analysis of high-risk situations and coping skills training. |
|
| Voucher Control | Behavioral | Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will be worth. |
|
| Completed Main Treatment on 400mg |
|
| COMPLETED | 'Completed' numbers reflect those that completed the post treatment assessments and 'Not Completed' numbers reflect those that did not complete the post treatment assessments. |
|
| NOT COMPLETED |
|
| BG002 | Sugar Pill Plus CM | Placebo: sugar pill Sugar Pill: placebo, sugar pill will mirror active drug |
| BG003 | Sugar Pill Plus Voucher Control | Placebo: sugar pill Sugar Pill: placebo, sugar pill will mirror active drug |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Sugar Pill Plus Contingency Management | Placebo: sugar pill Sugar Pill: placebo, sugar pill will mirror active drug Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample. |
| OG002 | Modafinil Plus Voucher Control | Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study. Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the |
| OG003 | Sugar Pill Plus Voucher Control | Sugar Pill: placebo, sugar pill will mirror active drug Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b |
|
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| Primary | Average Maximum Days Abstinent | Posted | Mean | Standard Deviation | days | up to 84 days |
|
|
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| Secondary | Average Number of Days Using a Substance Within Treatment | Posted | Mean | Standard Deviation | days | up to 90 days |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 11 |
| 26 |
| EG001 | Sugar Pill Plus Contingency Management | Placebo: sugar pill Sugar Pill: placebo, sugar pill will mirror active drug Contingency Management: Subjects in the CM conditions will earn vouchers for providing cocaine-free urine specimens. Subjects will be informed of the urine test results when available and, for subjects in the CM condition, receive a voucher at that time if the sample is negative. Subjects in the CM condition earn a minimum of $3 for each urine sample they submit that is negative for cocaine. Voucher amounts will escalate by $1 per consecutive clean urine sample submitted up to a maximum of $15 per clean sample. | 0 | 19 | 0 | 19 | 8 | 19 |
| EG002 | Modafinil Plus Voucher Control | Modafinil: Modafinil is started at 200mg on the first day of week 1 (treatment phase) and increased to 400mg by the end of that week. Subjects will continue to receive 400mg/day for the remainder of the study. Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that the | 0 | 19 | 0 | 19 | 5 | 19 |
| EG003 | Sugar Pill Plus Voucher Control | Sugar Pill: placebo, sugar pill will mirror active drug Voucher Control: Subjects in the Yoked-Control condition (YC) will be paired with a CM subject. Subjects in the YC condition will be informed that they will receive vouchers according to an unpredictable schedule, and that they cannot control when they will receive these vouchers or how much they will b | 0 | 27 | 0 | 27 | 6 | 27 |
| Agitation | Psychiatric disorders | Systematic Assessment |
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| Tired | General disorders | Systematic Assessment |
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| Drowsy | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Nightmare | General disorders | Systematic Assessment |
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| Depression | General disorders | Systematic Assessment |
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| anxiety | Psychiatric disorders | Systematic Assessment |
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| Numbness | Nervous system disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Decreased Appetite | Gastrointestinal disorders | Systematic Assessment |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D007659 | Ketones |
| Cocaine |
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| Heroine |
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| Any opiate |
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| Cocaine |
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| Heroin |
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| Opiate |
|