Nabilone in Cannabis Users With PTSD

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cannabis Post Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nabilone

Nabilone capsules (4 mg)

Group Type EXPERIMENTAL

Nabilone

Intervention Type DRUG

Nabilone capsules (4 mg)

Propranolol

Propranolol capsules (40mg)

Group Type ACTIVE_COMPARATOR

Propranolol

Intervention Type DRUG

Propranolol capsules (40mg)

Smoked cannabis

(0.0 and 5.6% THC)

Group Type EXPERIMENTAL

Cannabis

Intervention Type DRUG

Cigarettes (0.0 and 5.6% THC)

Placebo

Placebo capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo capsules

Interventions

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Nabilone

Nabilone capsules (4 mg)

Intervention Type DRUG

Cannabis

Cigarettes (0.0 and 5.6% THC)

Intervention Type DRUG

Propranolol

Propranolol capsules (40mg)

Intervention Type DRUG

Placebo

Placebo capsules

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No