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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA026777 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study is investigating how N-Acetylcysteine (NAC), an over-the-counter medication, will reduce marijuana use when combined with Contingency Management, a behavioral treatment. It is hypothesized that marijuana dependent adolescents who are treated with NAC will use less marijuana during treatment when compared to adolescents who receive a placebo.
This protocol involves investigation of N-Acetylcysteine (NAC) as a pharmacological treatment for cannabis dependence in adolescents. While recent advances have been made in psychosocial treatments for cannabis dependent adolescents, minimal work has been done to investigate the potential adjunctive role for pharmacotherapy in treatment. NAC is an inexpensive, over-the-counter agent with a favorable tolerability profile in adults and children, in common use since FDA approval in 1963. Preclinical and preliminary clinical research in adults suggests a role for NAC in addiction treatment via glutamate modulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetylcysteine | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetylcysteine | Drug | 1200 mg twice daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Negative Urine Cannabinoid Tests During Treatment | [Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100 | weekly during treatment, for 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin M Gray, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | N-Acetylcysteine | N-Acetylcysteine : 1200 mg twice daily for 8 weeks Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule |
| FG001 | Placebo | placebo : 2 capsules twice daily for 8 weeks Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N-Acetylcysteine | N-Acetylcysteine : 1200 mg twice daily for 8 weeks Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule |
| BG001 | Placebo |
| 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 | Percentage of Negative Urine Cannabinoid Tests During Treatment | [Total number of negative urine tests per Group divided by the total number of urine tests per Group]*100 | Posted | Number | percentage of negative urine tests | weekly during treatment, for 8 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 | N-Acetylcysteine | N-Acetylcysteine: 1200 mg twice daily for 8 weeks Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin M. Gray, Associate Professor | Medical University of South Carolina | 843-792-6330 | graykm@musc.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| placebo | Drug | 2 capsules twice daily for 8 weeks |
|
| Contingency Management | Behavioral | rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule |
|
placebo : 2 capsules twice daily for 8 weeks
Contingency Management : rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 24 |
| 58 |
| EG001 | Placebo | placebo: 2 capsules twice daily for 8 weeks Contingency Management: rewarding biologically verified marijuana abstinence during study visits, with an escalating reward schedule | 0 | 58 | 0 | 58 | 27 | 58 |
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | Systematic Assessment |
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| Decreased appetite | Gastrointestinal disorders | Systematic Assessment |
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| Drowsiness | Nervous system disorders | Systematic Assessment |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vivid dreams | Psychiatric disorders | Systematic Assessment |
|
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |