Cannabis, Post Traumatic Stress Disorder
Conditions
Brief summary
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.
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.
Interventions
DRUGNabilone
Nabilone capsules (4 mg)
DRUGCannabis
Cigarettes (0.0 and 5.6% THC)
DRUGPropranolol
Propranolol capsules (40mg)
DRUGPlacebo
Placebo capsules
Sponsors
National Institute on Drug Abuse (NIDA)
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Intervention model description
All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cue Reactivity (Emotional Stroop Task) | 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. |
Countries
United States
Participant flow
Pre-assignment details
The study was terminated and the PI and the study team left the institution; as such, no outcome data is available.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Nabilone/Propranolol/Placebo + Smoked Cannabis/Placebo Placebo |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 1 month
Population: 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.