Nabilone in Cannabis Users With PTSD

New York State Psychiatric Institute

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Post Traumatic Stress Disorder; Cannabis

Treatments: Drug: Nabilone; Drug: Propranolol; Drug: Cannabis; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03251326

6971 (Other Identifier)

U54DA037842 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

4 participants in 4 patient groups, including a placebo group

Nabilone

Experimental group

Description:

Nabilone capsules (4 mg)

Treatment:

Drug: Nabilone

Propranolol

Active Comparator group

Description:

Propranolol capsules (40mg)

Treatment:

Drug: Propranolol

Smoked cannabis

Experimental group

Description:

(0.0 and 5.6% THC)

Treatment:

Drug: Cannabis

Placebo

Placebo Comparator group

Description:

Placebo capsules

Treatment:

Drug: Placebo