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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DA023608-01 | U.S. NIH Grant/Contract | View source | |
| R01DA023608-01 | U.S. NIH Grant/Contract | View source | |
| DPMCDA | 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 and the development of a treatment for this disorder is a priority. To date, treatment interventions based on positive incentive principles have shown the strongest effects for improving substance use outcomes. One such example is contingency management (CM) interventions in which nondrug rewards are used to compete with cocaine. Recent evidence suggests that certain medications improve response to CM interventions, particularly agents that target dopamine reward systems in the brain. A promising dopamine-enhancing medication is levodopa. The study team has observed the strongest effects of levodopa when the medication is administered in the context of CM therapy, perhaps through mechanisms that enhance reward saliency. The proposed study is designed to further evaluate this promising treatment approach. Cocaine dependent outpatients will participate in a randomized, 2-group (levodopa vs. placebo), double-blind clinical trial. CM will be behavioral therapy platform for both treatment groups. The study will test the primary hypothesis that CM+levodopa will be more effective than CM+placebo in reducing cocaine use. This study is expected to validate the usefulness of a new behavioral-pharmacological treatment approach for cocaine dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levodopa pharmacotherapy | Experimental | Levodopa pharmacotherapy (800mg levodopa and 200mg carbidopa per day), cognitive behavioral therapy (CBT), and contingency management (CM). |
|
| Placebo | Placebo Comparator | Placebo, cognitive behavioral therapy (CBT), and contingency management (CM). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levodopa | Drug | 800mg levodopa and 200mg carbidopa per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Abstinence From Cocaine as Assessed by Treatment Effectiveness Score (TES) | The Treatment Effectiveness Score (TES) is the number of cocaine-negative urines collected out of the total scheduled urine tests for the 12-week trial (36 total scheduled urine tests per participant). The mean number of cocaine-negative urines over all time points is reported in this outcome measure. | 12 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy M Schmitz, PhD | University of Texas at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Levodopa Pharmacotherapy | Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM). |
| FG001 | Placebo | Placebo, cognitive behavioral therapy (CBT), and contingency management (CM). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Levodopa Pharmacotherapy | Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM). |
| BG001 | Placebo | Placebo, cognitive behavioral therapy (CBT), and contingency management (CM). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Confirmed Abstinence From Cocaine as Assessed by Treatment Effectiveness Score (TES) | The Treatment Effectiveness Score (TES) is the number of cocaine-negative urines collected out of the total scheduled urine tests for the 12-week trial (36 total scheduled urine tests per participant). The mean number of cocaine-negative urines over all time points is reported in this outcome measure. | Posted | Mean | Standard Deviation | cocaine-negative urines | 12 weeks of treatment |
|
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 | Levodopa Pharmacotherapy | Levodopa pharmacotherapy, cognitive behavioral therapy (CBT), and contingency management (CM). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
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Lower than expected rates of retention and medication compliance likely reduced the statistical power of the study for estimating treatment effects of the medication intervention.
| 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 |
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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 |
|---|---|
| D007980 | Levodopa |
| C009265 | carbidopa, levodopa drug combination |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo |
|
| Cognitive Behavioral Therapy | Behavioral | Participants received individual cognitive behavioral therapy (CBT) in 50-minute weekly sessions. These sessions were manual-driven and based on the relapse prevention model proposed by Marlatt and Gordon (1985). Trained masters-level therapists, under the supervision of senior therapists and the principal investigator, worked with participants to teach them how to recognize and cope with risky situations that could influence their cocaine use through self-monitoring of situational craving and drug use stimuli, coping skills training, and lifestyle modifications. |
|
| Contingency Management | Behavioral | An abstinence-based contingency management (CM) procedure was used. Participants earned vouchers according to the reward schedule recommended by Budney and Higgins (1998), beginning at $2.50 for the first cocaine-negative urine. For each consecutive cocaine-negative urine, voucher values increased by $1.25 with a $10 bonus given for provision of three consecutive cocaine-negative urines within a week. A cocaine-positive urine or failure to provide a scheduled urine sample resulted in a reset of the schedule to the initial value of $2.50. After provision of five negative urines, the voucher returned to the value prior to the reset. Participants were able to redeem their vouchers for small amounts of cash (≤$25) or gift cards for goods and services. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 6 |
| 45 |
| 0 |
| 45 |
| EG001 | Placebo | Placebo, cognitive behavioral therapy (CBT), and contingency management (CM). | 3 | 40 | 0 | 40 |
| Depression | Psychiatric disorders | Systematic Assessment |
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| Photosensitivity | Eye disorders | Systematic Assessment |
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| Head injury | General disorders | Systematic Assessment |
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| Suicide ideation | Psychiatric disorders | Systematic Assessment |
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| abscess | Infections and infestations | Systematic Assessment |
|
| Transient inability to speak | General disorders | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | Systematic Assessment |
|
| Blood clot | Vascular disorders | Systematic Assessment |
|
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| D002396 |
| Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014443 | Tyrosine |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |