- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04249882
A Novel Human Lab Model for Screening AUD Medications
A Novel Human Laboratory Model for Screening Medications for Alcohol Use Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recruitment: Participants will be recruited from the community through online and newspaper advertisements. Campaigns in local buses and print publications (e.g., LA Weekly) will also be implemented. Targeted recruitment will also take place through a lab database of previous study participants who agreed to be contacted for future studies.
Telephone Screen: Individuals who call the lab (in response to flyers and advertisements) expressing interest in the study will receive detailed information about the study procedures, and if they remain interested they will complete a telephone screen performed by a trained research assistant for self-reported inclusion and exclusion criteria. Those who appear eligible will be invited to the laboratory for an initial in-person screening session.
Initial Screening: Prior to conducting any research related procedures, research staff will conduct the informed consent process, which details the procedures to take place during the screening visit. Informed consent will be a three-part process. First, participants will be asked to read and provide verbal consent for breathalyzer. If the breathalyzer is above 0.000, the visit will be stopped and the participant will not be compensated. The participant will be given an opportunity to reschedule the visit for another day. If the breathalyzer test is negative, the written informed consent form will be reviewed and signed by the participant and study staff outlining procedures for the initial screening visit. A second written consent form will be reviewed and signed in the presence of the study physician at the medical screening visit if the participant is found eligible to continue to that visit. At the initial screening visit, subjects will be asked to provide a urine sample to test for drugs of abuse and pregnancy (if female), and will complete a series of questionnaires and interviews (described in detail below) to determine initial eligibility. This visit will take approximately 1 hour. Following the initial in-person screening, the study coordinator will meet with the PI to determine if the participant is eligible to continue to the medical screening based on study inclusion/exclusion criteria.
Medical Screening: Those participants who appear to be eligible after the initial screening visit, will then be scheduled for a second screening visit. This visit will be conducted by the study physician and will start with a breathalyzer test. If the breathalyzer is above 0.000, the visit will be stopped and the participant will not be compensated. The participant will be given an opportunity to reschedule the visit for another day. If the breathalyzer test is negative, the physician will conduct the second written (experimental) consent; medical history interview and physical exam. In addition, a urine sample will be obtained for repeat drug screen and pregnancy tests. The participant will then be accompanied by research personnel to the CTRC for blood specimen collection including Comprehensive Metabolic Panel and Complete Blood Count to evaluate overall health; and EKG to screen for medical conditions that could make study participation medically unsafe. The study physician will review each participant's medical history, vital signs, weight, review of systems, and laboratory tests, including liver function tests (LFTs), drug screen, chemistry screen, and urine pregnancy screen to determine if it is medically safe for the participant to take the study medication. Any subject who is excluded from the study will be compensated for their time in the screening session and will be offered referrals for alcohol treatment in the community.
Randomization and Medication Titration: Participants who are eligible after the physical exam will be randomized to one of three treatment conditions (VAR, NTX, or PLA). Urn randomization will be used to balance the groups by gender, smoking status (as reported on question 1 of the Fagerstrom Test for Nicotine Dependence), and drinking status ('heavy' drinker defined as 28 or more drinks per week for males/14 or more drinks per week for females, or 'very heavy' drinker, defined as 35 or more drinks per week for males/28 or more drinks per week for females). The UCLA Research Pharmacy will manage the blind. The three treatment conditions will not be different in appearance or method of administration. All participants will undergo a week-long medication titration period prior to the onset of the practice quit attempt.
Practice-Quit Attempt: During the practice-quit attempt, participants will be instructed to abstain completely from drinking alcohol during a 7-day practice quit period. This period will begin on Day 8 of study medication dosing. During this period, participants will complete daily virtual visits to report on their drinking, mood and craving for alcohol during the previous day in a daily diary assessment (DDA).
Study Medication: On Day 1, participants will report to the laboratory to complete the alcohol cue-reactivity paradigm and receive their first medication dose under direct observation of study staff. They will receive a 7-day supply of study medication in blister packs with AM and PM dosing clearly distinguished for the titration procedure. After reaching full medication dose at the end of one week, participants will come to the laboratory on Day 8 to begin the practice quit attempt and to take AM dose of study medication daily in the lab under direct observation of study staff. Additionally, on the first day of the practice-quit attempt (Day 8), participants will receive a second 7-day supply of study medication. All study medication will be prepared by the UCLA Research Pharmacy and will be identically matched in appearance (opaque capsules with 50 mg of riboflavin to aid in medication compliance procedures) and the medication labels will not reveal the drug identity.
Alcohol Cue Reactivity Sessions (CR): Randomized participants will complete a cue-exposure paradigm at two time points during the study, once on Day 1 prior to ingesting the first dose of study medication, and again on Day 14, approximately 90 minutes after study drug administration. Alcohol cue exposure will follow well-established experimental procedures. Sessions will begin with a 3-minute relaxation period. Participants will then hold and smell a glass of water for 3 minutes to control for the effects of simple exposure to any potable liquid. Next, participants will hold and smell a glass of their preferred alcoholic beverage for 3 minutes. Order is not counterbalanced because of carryover effects that are known to occur. Participants (who are smokers) will be allowed a smoke break immediately prior to the CR assessment. After every 3 minutes of exposure, participants will rate their urge to drink on the Alcohol Urge Questionnaire (AUQ) and their mood on the Profile of Mood States (POMS). AUQ score (alcohol minus water) is the primary outcome for the CR.
Brief Counseling Session: All participants will meet with a trained study counselor briefly after the second cue exposure session on Day 14 to discuss their responses to the alcohol cues and discuss local treatment options. The counselor will begin by introducing him/herself and thanking the participant for his/her participation. He/she will continue by providing the participant with feedback on their responses on various individual difference measures (drinking patterns, severity of AUD diagnosis, family history, CIWA, depression, and other drug use). The counselor will probe for participants' attitudes towards these responses and diagnoses, and provide both informational and emotional support. Next, the counselor will go over the participant's history of alcohol treatment, in order to identify potential barriers to treatment access. He/she will discuss local treatment options with the participant, including the participant's primary care provider, self-help groups, and the UCLA Psychology Clinic. Lastly, the counselor will go over the "Rethinking Drinking" pamphlet with the participant, pointing out specific treatment options discussed in the session, and will address any questions or concerns.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA Addictions Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be between the ages of 21 and 65
- Meet current (i.e., past 12-month) DSM-5 diagnostic criteria for AUD moderate or severe
- Have intrinsic motivation to reduce or quit drinking (defined as self-reported intention to reduce or quit drinking within the next 6 months)
- Report drinking at least 28 drinks per week if male (14 drinks per week if female) in the 28 days prior to the initial consent
- Have reliable internet access
Exclusion Criteria:
- Have a current (last 12 months) DSM-5 diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine
- Have a lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychotic disorder
- Have a positive urine screen for drugs other than cannabis
- Have clinically significant alcohol withdrawal symptoms as indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-R)
- Have an intense fear of needles or have had any adverse reactions to needle puncture
Be pregnant, nursing, or planning to become pregnant while taking part in the study; and must agree to one of the following methods of birth control (if female), unless she or partner are surgically sterile:
- Oral contraceptives
- Contraceptive sponge
- Patch
- Double barrier
- Intrauterine contraceptive device
- Etonogestrel implant
- Medroxyprogesterone acetate contraceptive injection
- Complete abstinence from sexual intercourse
- Hormonal vaginal contraceptive ring
- Have a medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes)
- Be currently taking any psychotropic medications that, in the opinion of the investigators, compromises participant safety
- Be currently taking or have had previous experience with either naltrexone or varenicline
- Have any other circumstances that, in the opinion of the investigators, compromises participant safety
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Matched to active medications
|
Matched to active medication
Other Names:
|
Active Comparator: Varenicline
1 mg twice a day
|
1 mg twice a day
Other Names:
|
Active Comparator: Naltrexone
50 mg once a day
|
50 mg once a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Days Abstinent
Time Frame: 6 days
|
The percentage of days abstinent from alcohol is determined using the Timeline Follow Back (TLFB).
The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14).
Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database.
The primary outcome variable was calculated as the percent of days participants were abstinent during the practice quit period.
|
6 days
|
# of Drinks Per Drinking Day
Time Frame: 6 days
|
The drinks per drinking day outcome is determined using the the Timeline Follow Back (TLFB).
The TLFB was administered to assess quantity and frequency of alcohol use each day during the practice quit period (Day 8 - Day 14).
Information obtained in this interview was recorded on the TLFB Calendar and transcribed to a database.
The primary outcome variable was calculated as the number of drinks per drinking day during the practice quit period.
|
6 days
|
Cue-induced Craving
Time Frame: Cue reactivity paradigm takes place on Day 1 and on Day 14. Craving is measured 3 min after each cue exposure
|
Randomized participants completed a cue-exposure paradigm at two time points during the study, once on Day 1 prior to ingesting the first does of study medication, and again on Day 14.
After every 3 minutes of exposure (water and alcohol), participants rated their urge to drink on the Alcohol Urge Questionnaire (AUQ).
The AUQ is comprised of eight items rated on a 7-point Likert scale with items related to the subjective experience of alcohol craving, with higher total scores indicating higher craving and a minimum score of 8 and maximum score of 56.
Alcohol urge questionnaire score (alcohol minus water) is the primary outcome for the cue-reactivity paradigm.
The investigators are primarily interested in the difference in craving from post-treatment (day 14) to pre-treatment (randomization/day 1).
|
Cue reactivity paradigm takes place on Day 1 and on Day 14. Craving is measured 3 min after each cue exposure
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lara Ray, PhD, University of California, Los Angeles
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Alcohol Drinking
- Alcoholism
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Sensory System Agents
- Narcotic Antagonists
- Nicotinic Agonists
- Cholinergic Agonists
- Alcohol Deterrents
- Naltrexone
- Varenicline
Other Study ID Numbers
- 19-001735
- R21AA027180 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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