Cannabidiol as a Treatment for AUD Comorbid With PTSD
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/23/2019 |
| Start Date: | April 15, 2019 |
| End Date: | August 31, 2019 |
| Contact: | Duna Abu-amara, MPH |
| Email: | Duna.Abu-amara@nyumc.org |
| Phone: | 646 754 4793 |
Cannabidiol as a Treatment for Alcohol Use Disorder Comorbid With Posttraumatic Stress Disorder
This project aims to determine whether cannabidiol (CBD), a compound derived from the
cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with
comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that
oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with
PTSD. To test this hypothesis, 50 otherwise healthy adult participants with moderate or
severe AUD and PTSD will be randomized to treatment with either CBD (400 mg daily) or
placebo, for a period of 6 weeks, such that both participants and study staff are blind to
treatment condition. Participants (each treated for 6 weeks) will be continuously recruited
over a study period of 14 months until 50 have completed. Baseline and weekly data will be
collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD
treatment leads to a greater improvement in these measures relative to placebo, and whether
reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects
will also participate in a task designed to quantify the psychological and physiological
links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving.
The task will be administered at baseline, before treatment, and following 6 weeks of
treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated
negative emotion between CBD and placebo groups will be compared. This study will be the
first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in
humans, and the first to examine the interaction between these treatment effects. Results
will serve as proof of concept and provide guidance for a future larger clinical trial.
Because CBD is a safe, readily available drug, such a trial would have an immense potential
to prevent death, medical illness, and psychological suffering associated with AUD and PTSD.
Further, because the brain circuits via which CBD acts to produce hypothesized effects are
relatively well-understood, results may substantially advance understanding of the
neurobiological basis of alcohol addiction.
cannabis plant, is effective in treating alcohol use disorder (AUD) in individuals with
comorbid posttraumatic stress disorder (PTSD). Investigators will test the hypothesis that
oral cannabidiol (CBD) will reduce alcohol drinking in individuals with AUD comorbid with
PTSD. To test this hypothesis, 50 otherwise healthy adult participants with moderate or
severe AUD and PTSD will be randomized to treatment with either CBD (400 mg daily) or
placebo, for a period of 6 weeks, such that both participants and study staff are blind to
treatment condition. Participants (each treated for 6 weeks) will be continuously recruited
over a study period of 14 months until 50 have completed. Baseline and weekly data will be
collected on alcohol usage and PTSD symptoms, and investigators will assess whether CBD
treatment leads to a greater improvement in these measures relative to placebo, and whether
reduction in alcohol drinking is temporally linked to improvement in PTSD symptoms. Subjects
will also participate in a task designed to quantify the psychological and physiological
links between negative emotion produced by re-experiencing PTSD trauma, and alcohol craving.
The task will be administered at baseline, before treatment, and following 6 weeks of
treatment. Treatment-associated reduction in alcohol craving elicited by trauma-associated
negative emotion between CBD and placebo groups will be compared. This study will be the
first to test whether CBD is effective in treating alcohol addiction and in treating PTSD in
humans, and the first to examine the interaction between these treatment effects. Results
will serve as proof of concept and provide guidance for a future larger clinical trial.
Because CBD is a safe, readily available drug, such a trial would have an immense potential
to prevent death, medical illness, and psychological suffering associated with AUD and PTSD.
Further, because the brain circuits via which CBD acts to produce hypothesized effects are
relatively well-understood, results may substantially advance understanding of the
neurobiological basis of alcohol addiction.
In this project, investigators aim to test the hypothesis that CBD will reduce alcohol
drinking in individuals with AUD comorbid with PTSD. CBD is currently a medical research
focus because it shows promise for treating anxiety and other brain disorders, but does not
produce a 'high' like other parts of cannabis, has not been shown to be addictive, and is
safe, with few or no side effects. AUD, which is one of the most common and most debilitating
psychiatric conditions, is often associated with other comorbid psychiatric disorders - in
particular, PTSD: depending on the population studied, 30-60% of individuals with AUD also
have PTSD, with high comorbidity rates in military veterans. Evidence from animal models and
clinical studies suggests that the negative emotion caused by PTSD symptoms intensifies
craving for alcohol during alcohol withdrawal, perpetuating the addictive cycle; further,
evidence shows that the brain circuits underlying negative emotion and addiction are linked
in a forebrain area called the extended amygdala, which provides a neuropharmacological
target to simultaneously treat both negative emotion and alcohol addiction in individuals
with AUD and PTSD. CBD is known to inhibit brain activity in the extended amygdala, leading
to reduced anxiety in both animal models and humans. CBD also reduces addictive alcohol
seeking in animal models.
drinking in individuals with AUD comorbid with PTSD. CBD is currently a medical research
focus because it shows promise for treating anxiety and other brain disorders, but does not
produce a 'high' like other parts of cannabis, has not been shown to be addictive, and is
safe, with few or no side effects. AUD, which is one of the most common and most debilitating
psychiatric conditions, is often associated with other comorbid psychiatric disorders - in
particular, PTSD: depending on the population studied, 30-60% of individuals with AUD also
have PTSD, with high comorbidity rates in military veterans. Evidence from animal models and
clinical studies suggests that the negative emotion caused by PTSD symptoms intensifies
craving for alcohol during alcohol withdrawal, perpetuating the addictive cycle; further,
evidence shows that the brain circuits underlying negative emotion and addiction are linked
in a forebrain area called the extended amygdala, which provides a neuropharmacological
target to simultaneously treat both negative emotion and alcohol addiction in individuals
with AUD and PTSD. CBD is known to inhibit brain activity in the extended amygdala, leading
to reduced anxiety in both animal models and humans. CBD also reduces addictive alcohol
seeking in animal models.
Inclusion Criteria:
- DSM-5 diagnosis of moderate or severe AUD
- At least 10 heavy drinking days in the month prior to screening, as assessed by the
Time Line Follow Back (TLFB)
- At least 3 heavy drinking days in the two weeks between screening and baseline (TLFB);
- DSM-5 diagnosis of PTSD, with a Clinician Administered PTSD Scale (CAPS) current
symptom score > 25
- Able to provide voluntary informed consent.
Exclusion Criteria:
- Current alcohol withdrawal (AW), evidenced by AW scale > 7
- Participants who report 50% greater reduction in drinks per day between screening and
randomization
- Severe psychiatric conditions, including past or current DSM5 diagnosis of
schizophrenia, schizoaffective disorder, bipolar disorder, or current suicidality
- DSM5 diagnosis of current moderate or severe substance use disorder for a substance
other than alcohol or nicotine
- Traumatic brain injury involving current concussive symptoms or a Post-Concussion
Syndrome score greater than or equal to 12
- Urine drug screen positive for cannabis use
- Exposure to trauma in the last 30 days, including police duty or military service
- Significant laboratory abnormalities, including significantly impaired hepatic
function*, abnormalities in complete blood count or metabolic panel
- 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
- Pregnancy or lactation.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: Charles Marmar, MD
Phone: 646-754-4793
New York University School of Medicine NYU School of Medicine has a proud history that...
Click here to add this to my saved trials
