Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 1/12/2019 |
| Start Date: | June 2012 |
| End Date: | December 2019 |
FAAH-Inhibitor for Cannabis Dependence
Cannabis dependence is associated with changes in the brain's cannabinoid system. When
cannabis dependent individuals try to quit using cannabis, some of them experience problems
that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the
problems related to quitting cannabis may facilitate abstinence. One way to do this is by
harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids.
One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the
problems related to quitting cannabis use will be reduced by increasing the brain levels of
anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will
be less likely to relapse. Brain anandamide levels will be increased by blocking the
breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of
a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied
in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent
subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The
trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient
treatment phase. Cannabis withdrawal will be measured during the inpatient phase. Cannabis
use and urinary THC-COOH levels will be measured during the entire study. The treatment phase
will be followed by a safety follow up phase of 8 weeks.
cannabis dependent individuals try to quit using cannabis, some of them experience problems
that make it difficult for them to achieve and maintain abstinence. Therefore, reducing the
problems related to quitting cannabis may facilitate abstinence. One way to do this is by
harnessing the brain's capacity to make its own cannabis-like substances - endocannabinoids.
One of the main endocannabinoids is anandamide. The study is based on the hypothesis that the
problems related to quitting cannabis use will be reduced by increasing the brain levels of
anandamide. Furthermore, by reducing the problems related to quitting cannabis, people will
be less likely to relapse. Brain anandamide levels will be increased by blocking the
breakdown of anandamide using a fatty acid amide hydrolase inhibitor (FAAH-I). The effects of
a novel FAAH-I cannabis withdrawal and relapse in cannabis dependent subjects will be studied
in a double-blind, randomized, controlled, proof-of-concept study. Cannabis-dependent
subjects will receive placebo or the FAAH-inhibitor PF-04457845 in a 2:1 randomization. The
trial consists of a 1 week inpatient stay to achieve abstinence, a 3 week outpatient
treatment phase. Cannabis withdrawal will be measured during the inpatient phase. Cannabis
use and urinary THC-COOH levels will be measured during the entire study. The treatment phase
will be followed by a safety follow up phase of 8 weeks.
Inclusion Criteria:
1. Male
2. Ages 18-55 (inclusive)
3. Cannabis Dependence
Exclusion Criteria:
1. Allergies or intolerance to FAAH-Inhibitors
2. Current significant medical or other comorbidities
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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