Add on Study on Δ9-THC Treatment for Posttraumatic Stress Disorders (PTSD)
NCT ID: NCT00965809
Last Updated: 2012-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2009-10-31
2013-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ACTIVE THC
Subjects will take 5MG of THC in 6 drops of olive oil orally.
Tetrahydrocannabinol
Five mg. of THC in 6 drops of olive oil orally twice a day for 6 weeks.
Placebo
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm
Placebo
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm
Interventions
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Tetrahydrocannabinol
Five mg. of THC in 6 drops of olive oil orally twice a day for 6 weeks.
Placebo
Subjects will take 6 drops of olive oil orally twice a day from an identical vial than those in the active arm
Eligibility Criteria
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Inclusion Criteria
* 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 .
* 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.
19 Years
60 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Hadassah University Hospital
Locations
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Hadassah Medical Organization
Jerusalem, , Israel
Countries
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Other Identifiers
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THC09
Identifier Type: -
Identifier Source: org_study_id