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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA037842-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The proposed protocol is a double-blind, placebo-controlled inpatient and outpatient study,looking at the clinical treatment of cannabis use disorder.
The treatment study is a total of 12 weeks. There will be two options offered to participants for week 1 of the treatment study. 1) Patient will go inpatient for 5 nights and after discharge from the inpatient phase will complete the 11-weeks of outpatient treatment or 2) patients who cannot complete the inpatient phase due to work or other obligations will complete the treatment 12-week study outpatient. 80 patients seeking treatment for cannabis use disorder will be enrolled into either the inpatient/outpatient or only outpatient study. This combined design will provide a comprehensive understanding of clonazepam's effects on individuals with cannabis use disorder across a range of outcome measures while also testing the medication's ability to prevent relapse in cannabis-abstinent patients.
Patients seeking treatment for Cannabis Use Disorder (CUD) will be enrolled into an inpatient laboratory for 5 nights, where they will be initiated on medication and be assessed for the influence of clonazepam (or placebo) on (1) cannabis withdrawal (mood, sleep, cannabis craving, food intake), ratings associated with medication abuse liability, cognitive performance, and (2) relapse to cannabis use after patients (now abstinent from cannabis) leave the inpatient setting maintained on clonazepam (or placebo) for 8 weeks (with a 4-week, medication-free follow up). This combined design will provide a comprehensive understanding of clonazepam's effects on individuals with cannabis use disorder across a range of outcome measures (safety, abuse liability, withdrawal symptoms) while also testing the medication's ability to prevent relapse in cannabis-abstinent patients. Patient's who are unable to complete the inpatient approach will complete the 12 week trial as an outpatient only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clonazepam | Experimental | Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial. |
|
| Placebo | Placebo Comparator | Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clonazepam | Drug | fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Cannabis Use Relapse | for inpatient participants the number of days till relapse to cannabis use, post inpatient discharge, as recorded on the time line follow-back and confirmed by urine toxicology. | Number of days during 12 weeks of study participation |
| Proportion of Cannabis Use Days Per Week | for outpatient participants the proportion of cannabis use days per week as recorded by the Timeline Followback method | the 7 weeks of study participation or length of participants participation during the medication maintenance phase |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Mariani, MD | New York Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Substance Treatment Research Service (STARS) of Columbia University | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clonazepam | Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial. Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial |
| FG001 | Placebo | Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Clonazepam | Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial. Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial |
| 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 | Time to Cannabis Use Relapse | for inpatient participants the number of days till relapse to cannabis use, post inpatient discharge, as recorded on the time line follow-back and confirmed by urine toxicology. | 11 participants started the study utilizing the inpatient approach | Posted | Median | Inter-Quartile Range | days | Number of days during 12 weeks of study participation |
|
Length of participant's participation, up to 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 | Clonazepam | Clonazepam will be taken twice per day in the morning and in the evening. Clonazepam is given in a "fixed flexible" dose schedule with the dose titrated to 2mg per day or the maximum tolerated dose. Clonazepam will be taken for the first 8 weeks of the trial. Clonazepam: fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychotic episode | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| insomnia | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Mariani MD | New York State Psychiatric Institute | 646-774-8181 | john.mariani@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2016 | Jun 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 15, 2016 | Jun 2, 2021 | SAP_001.pdf |
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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 |
|---|---|
| D002998 | Clonazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Placebo | Drug |
|
|
| BG001 | Placebo | Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial. Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marijuana Using days in prior 28 days at study start | Mean | Standard Deviation | days |
|
| Placebo |
Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial. Placebo |
|
|
| Primary | Proportion of Cannabis Use Days Per Week | for outpatient participants the proportion of cannabis use days per week as recorded by the Timeline Followback method | Posted | Mean | Standard Deviation | proportion of use days | the 7 weeks of study participation or length of participants participation during the medication maintenance phase |
|
|
|
| 0 |
| 34 |
| 1 |
| 34 |
| 27 |
| 34 |
| EG001 | Placebo | Placebo will be taken twice per day in the morning and in the evening. Placebo will be taken for the first 8 weeks of the trial. Placebo | 0 | 34 | 1 | 34 | 20 | 34 |
| suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| depression | Psychiatric disorders | Systematic Assessment |
|
| sedation | General disorders | Systematic Assessment |
|
| anxiety | Psychiatric disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| concentration issues | General disorders | Systematic Assessment |
|
| dizziness | General disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| abdominal pain | General disorders | Systematic Assessment |
|
| anorexia | General disorders | Systematic Assessment |
|
| bowel incontinence | Gastrointestinal disorders | Systematic Assessment |
|
| dental cavities | General disorders | Systematic Assessment |
|
| diminished libido | General disorders | Systematic Assessment |
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| erectile dysfunction | General disorders | Systematic Assessment |
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| flu | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| incoordination | General disorders | Systematic Assessment |
|
| increased appetite | General disorders | Systematic Assessment |
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| irritability | General disorders | Systematic Assessment |
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| itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| memory | General disorders | Systematic Assessment |
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| nightmares | General disorders | Systematic Assessment |
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| orthostasis | Cardiac disorders | Systematic Assessment |
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| psychosis | Psychiatric disorders | Systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| urinary incontinence | General disorders | Systematic Assessment |
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| sensitivity to cannabis | General disorders | Systematic Assessment |
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| palpitations | General disorders | Systematic Assessment |
|
| shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| delayed orgasm | General disorders | Systematic Assessment |
|
| elevated blood pressure | Cardiac disorders | Systematic Assessment |
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| drowsiness | General disorders | Systematic Assessment |
|
| GI upset | Gastrointestinal disorders | Systematic Assessment |
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| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| dry mouth | General disorders | Systematic Assessment |
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| backache | General disorders | Systematic Assessment |
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| chest discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
|
| mucous cyst | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Systematic Assessment |
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| testicular pain | General disorders | Systematic Assessment |
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| confusion | General disorders | Systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| week 3 |
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| week 4 |
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| week 5 |
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| week 6 |
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| week 7 |
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