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Alcohol Use Disorder and Cannabidiol

Primary Purpose

Alcohol Use Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cannabidiol
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring alcohol, cannabidiol, cbd, cannabis

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must be ≥21 years old. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms). Expresses desire to reduce or quit drinking. Meets one of the following drinking criteria: If male, reports drinking, on average, at least 21 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 14 standard drinks per week prior to screening Have at least one heavy drinking day (4 or more drinks per day for women/5 or more drinks per day for men) during the 7-day period prior to screening Able to attend in-person visits at the study site. Exclusion Criteria: Self-reported DSM-V diagnosis of any other substance use disorder. Current nicotine use. Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days. Daily cannabis use. Uses CBD products for medical reasons. Report having and being treated for a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder. Endorsing item 2 on the C-SSRS measure of suicide risk. Currently taking any of the following medications: Those known to have a major interaction with Epidiolex. Acute treatment with any antiepileptic medications. Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate). Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens). Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control. Current charges pending for a violent crime (not including DUI-related offenses). Lack of a stable living situation. Lack of access to internet.

Sites / Locations

  • University of Colorado AnschutzRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Full-Spectrum Cannabidiol

Broad-Spectrum Cannabidiol

Placebo

Arm Description

210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.

210mg/day of full-spectrum cannabidiol, containing 0.0% THC.

210mg/day of hemp seed oil with no cannabinoids present.

Outcomes

Primary Outcome Measures

Change in Drinks per Drinking Day
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Change in Alcohol Dependence/Craving
The AUDIT consists of ten questions that cover such domains as alcohol consumption, drinking behavior, adverse psychological reactions, and alcohol-related problems. HDD and alcohol dependence/craving are the primary behavioral outcomes that will be analyzed.

Secondary Outcome Measures

Change in Cue-reactivity
Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).
Change in Anxiety
The Depression Anxiety Stress Scale is a 21-item self-report instrument for measuring the three related negative emotional states of depression, anxiety, and tension/stress. Participants rate their anxiety on a scale from 1 (Did not apply to me at all) to 4 (Applied to me very much/most of the time), with higher scores indicating worse outcomes.
Change in Pain Levels
The PROMIS Numeric Rating Scale v1.0 - Pain Intensity - 1a consists of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain you can think of). Participants are also asked to rate the impact of their pain in the last 7 days. The PROMIS Short Form v1.1 - Pain Interference - 6b rates pain on a scale from 1 (not at all) to 5 (very much), as it refers to the degree to which pain limits or interferes with subjects' physical, mental, and social activities.
Change in Sleep Disturbance
The PROMIS Short Form v.1.0 - Sleep Disturbance - 4a will be used to measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days. This includes perceived difficulties falling asleep and staying asleep, as well as sleep satisfaction.

Full Information

First Posted
October 28, 2022
Last Updated
March 15, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05613608
Brief Title
Alcohol Use Disorder and Cannabidiol
Official Title
Alcohol Use Disorder and Cannabis: Testing Novel Harm Reduction Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Anticipated)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of full spectrum CBD and broad spectrum CBD, compared to a placebo control (PC), to reduce drinking in participants with alcohol use disorder. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks.
Detailed Description
To better understand the effects of hemp-derived CBD with and without a small amount of THC, we propose a Phase II randomized clinical trial (RCT) to examine the safety, tolerability, and clinical effects of Full Spectrum CBD (fsCBD, contains less than 0.3% THC) vs. Broad Spectrum CBD (bsCBD, does not contain THC), vs. a matching placebo in a population of AUD subjects. This is a double-blind, placebo-controlled, parallel group study designed to assess the efficacy of fsCBD and bsCBD, compared to a placebo control, to reduce drinking in participants with moderate alcohol use disorder according to the DSM-V. If eligible for the study, subjects will be randomized to receive one of the conditions for 12 weeks. The current study will test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety. It is further hypothesized that CBD will lead to increased sleep duration and quality among individuals with AUD who want to quit or reduce their drinking. The study will also determine whether the small amount of THC found in full spectrum hemp-derived CBD products produces any negative effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
alcohol, cannabidiol, cbd, cannabis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a double-blind, placebo-controlled, parallel group study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Full-Spectrum Cannabidiol
Arm Type
Active Comparator
Arm Description
210mg/day of full-spectrum cannabidiol, containing less than 0.3% THC.
Arm Title
Broad-Spectrum Cannabidiol
Arm Type
Active Comparator
Arm Description
210mg/day of full-spectrum cannabidiol, containing 0.0% THC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
210mg/day of hemp seed oil with no cannabinoids present.
Intervention Type
Drug
Intervention Name(s)
Cannabidiol
Intervention Description
The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo arm.
Primary Outcome Measure Information:
Title
Change in Drinks per Drinking Day
Description
The Time Line Follow Back is a calendar-assisted measure that can be used to assess alcohol, tobacco, cannabis, and other substance use. The investigators will use this measure to create the Drinks per Drinking Day variable.
Time Frame
0-12 weeks
Title
Change in Alcohol Dependence/Craving
Description
The AUDIT consists of ten questions that cover such domains as alcohol consumption, drinking behavior, adverse psychological reactions, and alcohol-related problems. HDD and alcohol dependence/craving are the primary behavioral outcomes that will be analyzed.
Time Frame
0-12 weeks
Secondary Outcome Measure Information:
Title
Change in Cue-reactivity
Description
Cue-elicited urge to drink will be assessed using the cue-reactivity assessment, per protocol (Hutchison, 2006).
Time Frame
0-12 weeks
Title
Change in Anxiety
Description
The Depression Anxiety Stress Scale is a 21-item self-report instrument for measuring the three related negative emotional states of depression, anxiety, and tension/stress. Participants rate their anxiety on a scale from 1 (Did not apply to me at all) to 4 (Applied to me very much/most of the time), with higher scores indicating worse outcomes.
Time Frame
0-12 weeks
Title
Change in Pain Levels
Description
The PROMIS Numeric Rating Scale v1.0 - Pain Intensity - 1a consists of a single item rating pain on average over the past 7 days from 0 (no pain) to 10 (worst pain you can think of). Participants are also asked to rate the impact of their pain in the last 7 days. The PROMIS Short Form v1.1 - Pain Interference - 6b rates pain on a scale from 1 (not at all) to 5 (very much), as it refers to the degree to which pain limits or interferes with subjects' physical, mental, and social activities.
Time Frame
0-12 weeks
Title
Change in Sleep Disturbance
Description
The PROMIS Short Form v.1.0 - Sleep Disturbance - 4a will be used to measure self-reported perceptions of sleep quality, depth, and restoration within the past seven days. This includes perceived difficulties falling asleep and staying asleep, as well as sleep satisfaction.
Time Frame
0-12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be ≥21 years old. Meets Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria for current Alcohol Use Disorder (AUD) of at least moderate severity (i.e., 4 or more DSM-V symptoms). Expresses desire to reduce or quit drinking. Meets one of the following drinking criteria: If male, reports drinking, on average, at least 21 standard alcoholic drinks per week prior to screening; if female, reports drinking, on average, at least 14 standard drinks per week prior to screening Have at least one heavy drinking day (4 or more drinks per day for women/5 or more drinks per day for men) during the 7-day period prior to screening Able to attend in-person visits at the study site. Exclusion Criteria: Self-reported DSM-V diagnosis of any other substance use disorder. Current nicotine use. Self-report illicit/recreational use of cocaine, methamphetamines, amphetamines, MDMA, opioids, or benzodiazepines in the last 30 days. Daily cannabis use. Uses CBD products for medical reasons. Report having and being treated for a serious DSM-V psychiatric disorder, including panic disorder, obsessive/compulsive disorder, post-traumatic stress disorder, bipolar affective disorder, schizophrenia, dissociative disorders, eating disorders, or any other psychotic or organic mental disorder. Endorsing item 2 on the C-SSRS measure of suicide risk. Currently taking any of the following medications: Those known to have a major interaction with Epidiolex. Acute treatment with any antiepileptic medications. Medication known to affect alcohol intake (e.g., disulfiram, naltrexone, acamprosate, and/or topiramate). Self-reported history of severe alcohol withdrawal (e.g., seizure, delirium tremens). Clinically significant medical problems in the last six months, such as cardiovascular, renal, gastrointestinal, or endocrine problems, that would impair participation or limit medication ingestion. Current or past alcohol-related medical illness, such as gastrointestinal bleeding, pancreatitis, hepatocellular disease, or peptic ulcer. Females of childbearing potential who are pregnant, nursing, or who are not using a reliable form of birth control. Current charges pending for a violent crime (not including DUI-related offenses). Lack of a stable living situation. Lack of access to internet.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaime Laurin, MS
Phone
3037242210
Email
jaime.laurin@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Raeghan Mueller, PhD
Phone
3037242210
Email
raeghan.mueller@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Hutchison, PhD
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaime Laurin, MS
Email
jaime.laurin@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Raeghan Mueller, PhD
Email
raeghan.mueller@cuanschutz.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified IPD will be made available on the NIMH Data Archive.
IPD Sharing Time Frame
The data will be submitted twice yearly with the first submission to occur in April 2023. The data will be available on the NIMH Data Archive indefinitely.
IPD Sharing URL
https://nda.nih.gov/

Learn more about this trial

Alcohol Use Disorder and Cannabidiol

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