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

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ClinicalTrials.gov Identifier: NCT00965809
Recruitment Status : Unknown
Verified September 2012 by Hadassah Medical Organization.
Recruitment status was:  Active, not recruiting
First Posted : August 26, 2009
Last Update Posted : October 30, 2012
Sponsor:
Information provided by:
Hadassah Medical Organization

Study Description
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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.


Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorders Drug: Tetrahydrocannabinol Other: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind, Placebo-Controlled Trial of THC as add-on Therapy for PTSD
Study Start Date : October 2009
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : April 2013

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Clinician Administered PTSD Scale [ Time Frame: Baseline and end o ftreatment ]

Secondary Outcome Measures :
  1. Nightmare Frequency Questionaire Score [ Time Frame: Baseline Weeks 3 &6 (EOS) ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00965809


Locations
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Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
More Information
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Responsible Party: Arieh Y. Shalev, M.D. / Head, Department of Psychiatry, Hadassah University Hospital
ClinicalTrials.gov Identifier: NCT00965809    
Other Study ID Numbers: THC09
First Posted: August 26, 2009    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: September 2012
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Dronabinol
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists