Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD) (THC_PTSD)

Double Blind, Placebo-Controlled Trial of THC as add-on Therapy for PTSD

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.

Study Overview

• Status: Unknown
• Conditions: Posttraumatic Stress Disorders
• Intervention / Treatment: Drug: Tetrahydrocannabinol; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Clinician Administered PTSD Scale	Baseline and end o ftreatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Nightmare Frequency Questionaire Score	Baseline Weeks 3 &6 (EOS)

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 25, 2009
• First Posted (Estimate): August 26, 2009

Study Record Updates

• Last Update Posted (Estimate): October 30, 2012
• Last Update Submitted That Met QC Criteria: October 28, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol
• Other Study ID Numbers: THC09