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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
The purpose of this study is to examine the effects of the administration of Risperidal-Consta on the brain's reward circuitry using Magnetic resonance Imaging (MRI), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Identical placebo tablets and injections |
|
| risperidone consta | Active Comparator | Risperidone 1-2 mg tablets and Risperidone 25 mg injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues | Measure of Dispersion/Precision not calculated, and raw data are no longer available | 12 weeks |
| Cocaine Use by Quantitative Urine Samples | After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Craving | The University of Minnesota Cocaine Craving Scale was performed to assess cocaine craving. The scale contains 1 continuous scale for intensity and 2 categorical scales for frequency and duration of craving episodes. The continuous scale for craving intensity ranges from 0 (no craving at all in the past week) to 10 (a great deal of craving in the past week) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eden A Evins, MD MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MGH Addiction Research Program | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18294021 | Derived | Loebl T, Angarita GA, Pachas GN, Huang KL, Lee SH, Nino J, Logvinenko T, Culhane MA, Evins AE. A randomized, double-blind, placebo-controlled trial of long-acting risperidone in cocaine-dependent men. J Clin Psychiatry. 2008 Mar;69(3):480-6. doi: 10.4088/jcp.v69n0321. |
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After baseline evaluation participants began treatment with oral risperidone, 1 mg per day the first week and 2 mg per day for the next 3 weeks. Electrocardiograms were repeated after 1 and 2 weeks of risperidone use. Participants with corrected QT interval (QTc) prolongation greater than 470 milliseconds at either of these occasions were excluded
Participants were recruited from October 2005 to September 2006 via advertisement in local press
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Identical placebo tablets and injections |
| FG001 | Risperidone Consta | Risperidone 1-2 mg tablets and Risperidone 25 mg injections |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Identical placebo tablets and injections |
| BG001 | Risperidone Consta | Risperidone 1-2 mg tablets and Risperidone 25 mg injections |
| 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 | Functional MRI Activation Patterns in the Nucleus Accumbens and Amygdala in Response to Cocaine Cues | Measure of Dispersion/Precision not calculated, and raw data are no longer available | Measure of Dispersion/Precision not calculated, and raw data are no longer available | Posted | 12 weeks |
|
Adverse event data was collected at every 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 | Placebo | Identical placebo tablets and injections |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased appetite | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| A. Eden Evins, MD, MPH. Director of the MGH-Harvard Center for Addiction Medicine | Massachusetts General Hospital - Harvard Medical School | 6176434679 | a_eden_evins@hms.harvard.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 |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Amygdala Volume by MRI | Measure of Dispersion/Precision not calculated, and raw data are no longer available | 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
| Primary | Cocaine Use by Quantitative Urine Samples | After randomization, participants provided urine samples every week for the first 3 weeks and then every 2 weeks for 8 weeks, up to 7 samples per participant. The average visits with cocaine negative urine samples per participant are reported below | Mean number of visits at which participants submitted urine samples with undetectable urine benzoylecgonine (UBE) | Posted | Mean | Standard Deviation | visit with negative UBE | 12 weeks |
|
|
|
| Secondary | Cocaine Craving | The University of Minnesota Cocaine Craving Scale was performed to assess cocaine craving. The scale contains 1 continuous scale for intensity and 2 categorical scales for frequency and duration of craving episodes. The continuous scale for craving intensity ranges from 0 (no craving at all in the past week) to 10 (a great deal of craving in the past week) | Mixed model repeated measures analysis of variance was performed. | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Amygdala Volume by MRI | Measure of Dispersion/Precision not calculated, and raw data are no longer available | Measure of Dispersion/Precision not calculated, and raw data are no longer available | Posted | 12 weeks |
|
|
| 0 |
| 15 |
| 7 |
| 15 |
| EG001 | Risperidone Consta | Risperidone 1-2 mg tablets and Risperidone 25 mg injections | 0 | 16 | 13 | 16 |
| Common cold | Respiratory, thoracic and mediastinal disorders |
|
| Sexual dysfunction | Reproductive system and breast disorders |
|
| Insomnia | General disorders |
|
| Dizziness | General disorders |
|
| Dry mouth | General disorders |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders |
|
| Dyspepsia | Gastrointestinal disorders |
|
| Fatigue | General disorders |
|
| Somnolence | General disorders |
|
| Depression | Psychiatric disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Increased thirst | General disorders |
|
| Muscle rigidity, twitches | Nervous system disorders |
|
| Increased urination | General disorders |
|
| Fever | General disorders |
|
| Parasthesia, hypoesthesia | Nervous system disorders |
|
| Akathisia | Nervous system disorders |
|
| Tardive dyskinesia | Nervous system disorders |
|
| Other | General disorders |
|
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