Overview

This trial is active, not recruiting.

Condition posttraumatic stress disorders
Treatments tetrahydrocannabinol, placebo
Phase phase 4
Sponsor Hadassah Medical Organization
Start date October 2009
End date October 2012
Trial size 70 participants
Trial identifier NCT00965809, THC09

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Subjects will take 5MG of THC in 6 drops of olive oil orally.
tetrahydrocannabinol
Five mg. of THC in 6 drops of olive oil orally twice a day for 6 weeks.
(Placebo Comparator)
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm
placebo
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm

Primary Outcomes

Measure
Clinician Administered PTSD Scale
time frame: Baseline and end o ftreatment

Secondary Outcomes

Measure
Nightmare Frequency Questionaire Score
time frame: Baseline Weeks 3 &6 (EOS)

Eligibility Criteria

Male or female participants from 19 years up to 60 years old.

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.

Additional Information

Official title Double Blind, Placebo-Controlled Trial of THC as add-on Therapy for PTSD
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Hadassah Medical Organization.