Nabilone in Cannabis Users With PTSD

NCT03251326 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: 6971U54DA037842
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Nabilone

EXPERIMENTAL

Nabilone capsules (4 mg)

Drug: Nabilone

Propranolol

ACTIVE COMPARATOR

Propranolol capsules (40mg)

Drug: Propranolol

Smoked cannabis

EXPERIMENTAL

(0.0 and 5.6% THC)

Drug: Cannabis

Placebo

PLACEBO COMPARATOR

Placebo capsules

Drug: Placebo

Interventions

Nabilone DRUG

Nabilone capsules (4 mg)

Nabilone

Cannabis DRUG

Cigarettes (0.0 and 5.6% THC)

Smoked cannabis

Propranolol DRUG

Propranolol capsules (40mg)

Propranolol

Placebo DRUG

Placebo capsules

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Stress Disorders, Post-Traumatic

Interventions

nabilone; nabiximols; Propranolol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Margaret Haney, Ph.D.
• Organization: New York State Psychiatric Institute

meg.haney@nyspi.columbia.edu

646-774-6129

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurobiology (in Psychiatry) at CUMC

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

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 16, 2017
• Study Start: October 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: July 15, 2022
• Results First Posted: October 12, 2020

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)