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

NCT00965809 | Unknown Phase 4

• 1 other identifier: THC09
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Posttraumatic Stress Disorders

Outcome Measures

Primary Outcomes (1)

• Clinician Administered PTSD Scale

  Baseline and end o ftreatment

Secondary Outcomes (1)

• Nightmare Frequency Questionaire Score

  Baseline Weeks 3 &6 (EOS)

Study Arms (2)

ACTIVE THC

EXPERIMENTAL

Subjects will take 5MG of THC in 6 drops of olive oil orally.

Drug: Tetrahydrocannabinol

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Tetrahydrocannabinol DRUG

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

ACTIVE THC

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2009
• First Posted: August 26, 2009
• Study Start: October 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2013
• Last Updated: October 30, 2012

Record last verified: 2012-09

Locations

IL (1)