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| ID | Type | Description | Link |
|---|---|---|---|
| U54DA037842 | U.S. NIH Grant/Contract | View source |
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Recruitment difficulties
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Despite the prevalence of cannabis use among the PTSD population and self-reports that it is used to help cope with PTSD symptoms, the direct effects of cannabis on PTSD symptomology are unknown. The purpose of this placebo-controlled, within-subject study is to assess the effects of smoked cannabis and orally administered nabilone, a synthetic analog of THC, the primary psychoactive component of cannabis on multiple dimensions of PTSD symptomatology in cannabis smokers with PTSD.
This study will compare the effects of smoked cannabis and nabilone on attentional bias toward trauma- related stimuli, subjective and emotional processing to a range of trauma-and non-trauma-related images and physiological reactivity to these stimuli in individuals with CUD and PTSD. Importantly, this study will also probe the abuse related potential of nabilone compared to smoked cannabis in this population, a critical aspect in determining the potential feasibility for its use clinically to treat CUD in PTSD populations. The effects of nabilone will be compared to propranolol as a positive control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nabilone | Experimental | Nabilone capsules (4 mg) |
|
| Propranolol | Active Comparator | Propranolol capsules (40mg) |
|
| Smoked cannabis | Experimental | (0.0 and 5.6% THC) |
|
| Placebo | Placebo Comparator | Placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nabilone | Drug | Nabilone capsules (4 mg) |
| |
| Cannabis |
| Measure | Description | Time Frame |
|---|---|---|
| Cue Reactivity (Emotional Stroop Task) | We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data. | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
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The study was terminated and the PI and the study team left the institution; as such, no outcome data is available.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Nab > Plac Prop > Plac Cann | Nabilone capsules (4 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC) |
| FG001 | Plac Nab > Act Prop > Plac Cann | Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC) |
| FG002 | Plac Nab > Plac Prop > Act Cann | Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC) |
| FG003 | Plac Nab > Plac Prop > Plac Cann | Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nabilone/Propranolol/Placebo + Smoked Cannabis/Placebo Placebo | Nabilone capsules (4 mg) Propranolol (40mg) Placebo (0mg nabilone or propranolol) Placebo cannabis (0.0% THC) Smoked cannabis (5.6% THC) |
| 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 | Cue Reactivity (Emotional Stroop Task) | We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data. | We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data. | Posted | 1 month |
|
Adverse events were collected throughout the duration of the study (October 2015 - June 2019). Each participant's was enrolled in the study for approximately 1.5 months, during which adverse event data was collected (baseline through each of 4 experimental sessions).
We cannot provide data as the study was terminated due to lack of feasibility. The staff responsible for data collection, organization, and cleaning have left the institution; we have made every effort to locate the data for the two participants who completed the study, but have been unsuccessful. We do not have access to the data.
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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 | Active Nab > Plac Prop > Plac Cann | Nabilone capsules (4 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Haney, Ph.D. | New York State Psychiatric Institute | 646-774-6129 | meg.haney@nyspi.columbia.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2018 | Sep 17, 2020 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
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| ID | Term |
|---|---|
| C011941 | nabilone |
| C587251 | nabiximols |
| D011433 | Propranolol |
| ID | Term |
|---|---|
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).
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| Drug |
Cigarettes (0.0 and 5.6% THC) |
|
| Propranolol | Drug | Propranolol capsules (40mg) |
|
| Placebo | Drug | Placebo capsules |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Plac Nab > Act Prop > Plac Cann | Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC) |
| OG002 | Plac Nab > Plac Prop > Act Cann | Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC) |
| OG003 | Plac Nab > Plac Prop > Plac Cann | Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC) |
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Plac Nab > Act Prop > Plac Cann | Nabilone placebo capsules (0 mg) Propranolol capsules (40mg) Placebo cannabis (0.0% THC) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Plac Nab > Plac Prop > Act Cann | Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Smoked cannabis (5.6% THC) | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Plac Nab > Plac Prop > Plac Cann | Nabilone placebo capsules (0 mg) Propranolol placebo capsules (0 mg) Placebo cannabis (0.0% THC) | 0 | 0 | 0 | 0 | 0 | 0 |
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| D000068099 | Trauma and Stressor Related Disorders |
| D009930 |
| Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |