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

Posttraumatic Stress Disorders Clinical Trial

— THC_PTSD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00965809
• Other study ID #: THC09
• Status: Active, not recruiting
• Phase: Phase 4
• First received: August 25, 2009
• Last updated: October 28, 2012
• Start date: October 2009
• Est. completion date: April 2013

Study information

• Verified date: September 2012
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Tetrahydrocannabinol
Five mg. of THC in 6 drops of olive oil orally twice a day for 6 weeks.

Other:
• Placebo
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale		Baseline and end o ftreatment	No
Secondary	Nightmare Frequency Questionaire Score		Baseline Weeks 3 &6 (EOS)	No