- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03251326
Nabilone in Cannabis Users With PTSD
June 29, 2022 updated by: Margaret Haney, New York State Psychiatric Institute
Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Current cannabis use
- PTSD symptoms
- Able to give informed consent and comply with study procedures
- Women who are normally cycling and practicing an effective form of birth control other than hormonal contraceptives
Exclusion Criteria:
- Meeting criteria for certain current psychiatric disorders
- Clinical laboratory tests outside of normal limits
- History of clinically significant cardiac or respiratory diagnoses
- Current parole or probation
- Women who are currently pregnant or breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo capsules
|
Placebo capsules
|
Experimental: Nabilone
Nabilone capsules (4 mg)
|
Nabilone capsules (4 mg)
|
Active Comparator: Propranolol
Propranolol capsules (40mg)
|
Propranolol capsules (40mg)
|
Experimental: Smoked cannabis
(0.0 and 5.6% THC)
|
Cigarettes (0.0 and 5.6% THC)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cue Reactivity (Emotional Stroop Task)
Time Frame: 1 month
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
August 14, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (Actual)
August 16, 2017
Study Record Updates
Last Update Posted (Actual)
July 15, 2022
Last Update Submitted That Met QC Criteria
June 29, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Trauma and Stressor Related Disorders
- Stress Disorders, Traumatic
- Stress Disorders, Post-Traumatic
- Marijuana Abuse
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Propranolol
- Nabilone
Other Study ID Numbers
- 6971 (University of Washington Medical Center)
- U54DA037842 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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