Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD)
Information source: Hadassah Medical Organization
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Posttraumatic Stress Disorders
Intervention: Tetrahydrocannabinol (Drug); Placebo (Other)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Hadassah Medical Organization Overall contact:
Pablo A Roitman, MD, Phone: 00972-2-6777184, Email: pablo@hadassah.org.il
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.
Clinical Details
Official title: Double Blind, Placebo-Controlled Trial of THC as add-on Therapy for PTSD
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinician Administered PTSD Scale
Secondary outcome: Nightmare Frequency Questionaire Score
Eligibility
Minimum age: 19 Years.
Maximum age: 60 Years.
Gender(s): Both.
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.
Locations and Contacts
Pablo A Roitman, MD, Phone: 00972-2-6777184, Email: pablo@hadassah.org.il
Hadassah Medical Organization, Jerusalem 91120, Israel
Additional Information
Starting date: October 2009
Ending date: July 2010
Last updated: August 25, 2009
|
