Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD) - Full Text View

Sponsor:	Hadassah Medical Organization
Information provided by:	Hadassah Medical Organization
ClinicalTrials.gov Identifier:	NCT00965809

Purpose

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.

Condition	Intervention	Phase
Posttraumatic Stress Disorders	Drug: Tetrahydrocannabinol Other: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Double Blind, Placebo-Controlled Trial of THC as add-on Therapy for PTSD

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Post-Traumatic Stress Disorder

Drug Information available for: Tetrahydrocannabinol

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:

Clinician Administered PTSD Scale [ Time Frame: Baseline and end o ftreatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Nightmare Frequency Questionaire Score [ Time Frame: Baseline Weeks 3 &6 (EOS) ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	October 2009
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ACTIVE THC Subjects will take 5MG of THC in 6 drops of olive oil orally.	Drug: Tetrahydrocannabinol Five mg. of THC in 6 drops of olive oil orally twice a day for 6 weeks.
Placebo Comparator: Placebo Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm	Other: Placebo Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm

Eligibility

Ages Eligible for Study:	19 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965809

Contacts

Contact: Pablo A Roitman, MD

00972-2-6777184

pablo@hadassah.org.il

Locations

Israel
Hadassah Medical Organization	Recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il
Principal Investigator: Arieh Y Shalev, MD
Sub-Investigator: Pablo A Roitman, M.D
Sub-Investigator: Raphael Mechoulam, Profesor of Med Chemistry

Sponsors and Collaborators

Hadassah Medical Organization

More Information

No publications provided

Responsible Party:	Arieh Y. Shalev, M.D. / Head, Department of Psychiatry, Hadassah University Hospital
ClinicalTrials.gov Identifier:	NCT00965809 History of Changes
Other Study ID Numbers:	THC09
Study First Received:	August 25, 2009
Last Updated:	July 6, 2011
Health Authority:	Israel: Ministry of Health

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Tetrahydrocannabinol
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012