Effects of Cannabidiol in Alcohol Use Disorder
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/27/2019 |
| Start Date: | April 15, 2019 |
| End Date: | January 2020 |
| Contact: | Tara Malone |
| Email: | tara.malone@nyumc.org |
| Phone: | 646-501-4026 |
The goal of the proposed project is to begin rigorous study of the clinically relevant
effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe
alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is
designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD
to those of placebo in AUD patients. Participants with AUD will be randomized to receive
either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO)
for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD
levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include
circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and
motoric function), and physiological and psychological domains relevant to AUD (including
self-reported craving, depression, and anxiety, and responses to personalized scripts
designed to elicit stress- and cue-induced craving and anxiety). Assessments will be
conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs.
placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks
of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.
effects of non-psychoactive phytocannabinoid cannabidiol (CBD) in patients with severe
alcohol use disorder (AUD). This double-blind, randomized proof-of-concept study (n = 40) is
designed to assess feasibility and contrast effects of extended (8 weeks) treatment with CBD
to those of placebo in AUD patients. Participants with AUD will be randomized to receive
either placebo or 600mg CBD/day (PO) for 4 weeks, immediately followed by 1200mg CBD/day (PO)
for an additional 4 weeks (8 total weeks). These doses were chosen to reproduce serum CBD
levels reported to reduce alcohol-seeking behavior in animal studies. Measures will include
circulating levels of CBD, safety measures (THC serum levels, adverse events, cognitive and
motoric function), and physiological and psychological domains relevant to AUD (including
self-reported craving, depression, and anxiety, and responses to personalized scripts
designed to elicit stress- and cue-induced craving and anxiety). Assessments will be
conducted following 1 day, 1 week, and 4 weeks of treatment with each dose of CBD vs.
placebo, and 1 and 4 weeks after the cessation of treatment. Drinking outcomes across 8 weeks
of treatment and 4 weeks of follow-up will also be assessed as an exploratory outcome.
There is increasing recognition of the roles of the endocannabinoid system in neurobiological
processes and behavioral domains relevant to addiction. The non-psychoactive phytocannabinoid
cannabidiol (CBD) has attracted considerable attention due to its lack of abuse potential,
its excellent safety profile, its unique and complex pharmacology, and evidence that it
affects anxiety and stress response in animal models and humans. There is a growing body of
preclinical data demonstrating that CBD produces marked and persisting decreases in alcohol
self-administration and preference for alcohol, and alcohol-, cue- and stress-induced
reinstatement of alcohol-seeking behavior, yet there are few studies of the effects of CBD in
humans with addictive disorders, and none in alcohol dependent patients.
processes and behavioral domains relevant to addiction. The non-psychoactive phytocannabinoid
cannabidiol (CBD) has attracted considerable attention due to its lack of abuse potential,
its excellent safety profile, its unique and complex pharmacology, and evidence that it
affects anxiety and stress response in animal models and humans. There is a growing body of
preclinical data demonstrating that CBD produces marked and persisting decreases in alcohol
self-administration and preference for alcohol, and alcohol-, cue- and stress-induced
reinstatement of alcohol-seeking behavior, yet there are few studies of the effects of CBD in
humans with addictive disorders, and none in alcohol dependent patients.
Inclusion Criteria:
- DSM-5 diagnosis of moderate or severe AUD
- able to provide voluntary informed consent
- at least 10 heavy drinking days (4 or more drinks for a woman, 5 or more drinks for a
man) in the 30 days prior to screen
- not currently in treatment for AUD
Exclusion Criteria:
- current alcohol withdrawal (CIWA-Ar score >7)\
- exclusionary medical conditions (e.g. current severe alcohol withdrawal requiring
medical hospitalization, significantly impaired liver function);
- DSM-5 diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder,
- Current suicidality
- DSM-5 diagnosis of current moderate or severe substance use disorder for a -substance
other than alcohol or nicotin
- marijuana or other cannabinoid use within 30 days prior to screen
- Significant laboratory abnormalities, including significantly impaired liver function,
serious abnormalities of complete blood count or metabolic panel
- active legal problems likely to result in incarceration within 12 weeks of treatment
initiation
- pregnancy or lactation
- Current use of exclusionary medications, including those acting on serotonergic
pathways, antipsychotics, anticonvulsants, and psychostimulants, treatments for
addictions including alcohol, and medications metabolized primarily by CYP3A4, CYP3A5,
or CYP3A7
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