search
Back to results

Nabilone in Cannabis Users With PTSD

Primary Purpose

Cannabis, Post Traumatic Stress Disorder

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nabilone
Cannabis
Propranolol
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Placebo Comparator

Arm Label

Nabilone

Propranolol

Smoked cannabis

Placebo

Arm Description

Nabilone capsules (4 mg)

Propranolol capsules (40mg)

(0.0 and 5.6% THC)

Placebo capsules

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2017
Last Updated
June 29, 2022
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT03251326
Brief Title
Nabilone in Cannabis Users With PTSD
Official Title
Effects of Nabilone on Trauma Related Cue Reactivity in Cannabis Users With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
October 2015 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis, Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
All patients will contribute to each of 4 drug conditions (placebo, nabilone, smoked cannabis, and propranolol).
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nabilone
Arm Type
Experimental
Arm Description
Nabilone capsules (4 mg)
Arm Title
Propranolol
Arm Type
Active Comparator
Arm Description
Propranolol capsules (40mg)
Arm Title
Smoked cannabis
Arm Type
Experimental
Arm Description
(0.0 and 5.6% THC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsules
Intervention Type
Drug
Intervention Name(s)
Nabilone
Intervention Description
Nabilone capsules (4 mg)
Intervention Type
Drug
Intervention Name(s)
Cannabis
Intervention Description
Cigarettes (0.0 and 5.6% THC)
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
Propranolol capsules (40mg)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules
Primary Outcome Measure Information:
Title
Cue Reactivity (Emotional Stroop Task)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Nabilone in Cannabis Users With PTSD

We'll reach out to this number within 24 hrs