Back to resultsAdd on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD) (THC_PTSD)
Primary Purpose
Posttraumatic Stress Disorders
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Tetrahydrocannabinol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorders
Eligibility Criteria
Inclusion Criteria:
- Outpatients between the 19-60 years of age with a diagnosis of PTSD.
- Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study.
- Subjects must be on stable medication (4 weeks minimum) for their PTSD (symptomatic despite current treatment), must be able to provide written informed consent, must be able adequately understand and comply with the study's instructions and protocol .
Exclusion Criteria:
- Those not meeting the inclusion criteria and those not able to give informed consent.
- Women who are currently pregnant or nursing.
- Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness;
- currently abusing alcohol or drugs;
- currently being treated with an investigational medication or medication that is contraindicated with cannabinoids;
- have a known allergy to cannabis-based products.
Sites / Locations
- Hadassah Medical Organization
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ACTIVE THC
Placebo
Arm Description
Subjects will take 5MG of THC in 6 drops of olive oil orally.
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm
Outcomes
Primary Outcome Measures
Clinician Administered PTSD Scale
Secondary Outcome Measures
Nightmare Frequency Questionaire Score
Full Information
NCT ID
NCT00965809
First Posted
August 25, 2009
Last Updated
October 28, 2012
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT00965809
Brief Title
Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD)
Acronym
THC_PTSD
Official Title
Double Blind, Placebo-Controlled Trial of THC as add-on Therapy for PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
April 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
Brief Summary
Stress Disorder (PTSD) is a chronic and debilitating anxiety disorder which is widespread in every social level and is very prevalent in outpatient and inpatient settings.
A recent open-label study showed that the synthetic cannabinoid receptor agonist Nabilone had beneficial effects abolishing or greatly reducing nightmares that persisted in spite of treatment with conventional PTSD medications. Furthermore, a big number of patients suffering from chronic PTSD report using smoked marijuana because its tranquilizing effect and sleep quality improvement. According to clinical and epidemiological data different derivates from the cannabis plant are illegally and pervasively consumed by PTSD patients in order to reduce distress.
The aim of the proposed study is to broaden the previous observations and to measure the extent to which Δ 9-THC will bring to significant improvement on the full spectrum of PTSD symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACTIVE THC
Arm Type
Experimental
Arm Description
Subjects will take 5MG of THC in 6 drops of olive oil orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm
Intervention Type
Drug
Intervention Name(s)
Tetrahydrocannabinol
Intervention Description
Five mg. of THC in 6 drops of olive oil orally twice a day for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale
Time Frame
Baseline and end o ftreatment
Secondary Outcome Measure Information:
Title
Nightmare Frequency Questionaire Score
Time Frame
Baseline Weeks 3 &6 (EOS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients between the 19-60 years of age with a diagnosis of PTSD.
Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study.
Subjects must be on stable medication (4 weeks minimum) for their PTSD (symptomatic despite current treatment), must be able to provide written informed consent, must be able adequately understand and comply with the study's instructions and protocol .
Exclusion Criteria:
Those not meeting the inclusion criteria and those not able to give informed consent.
Women who are currently pregnant or nursing.
Those at immediate risk of harming self or others; those who have a clinically significant medical illness or other significant psychiatric illness;
currently abusing alcohol or drugs;
currently being treated with an investigational medication or medication that is contraindicated with cannabinoids;
have a known allergy to cannabis-based products.
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD)
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