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Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo

Sponsor
The Scripps Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04466215
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
50
Enrollment
1
Location
2
Arms
13.7
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or greater severity treated with CORT118335 will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Parallel Assignment, Double-Blind, RandomizedParallel Assignment, Double-Blind, Randomized
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo
Actual Study Start Date :
Apr 15, 2021
Actual Primary Completion Date :
Apr 15, 2022
Actual Study Completion Date :
Jun 7, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CORT118335

900 mg (6 x 150 mg) tablets daily taken orally for two weeks

Drug: CORT118335
900 mg (6 x 150 mg) tablets taken orally once daily for two weeks
Placebo Comparator: Placebo

Six placebo tablets taken orally for two weeks

Drug: Placebo oral tablet
Six placebo tablets taken orally once daily for two weeks

Outcome Measures

Primary Outcome Measures

  1. Craving to drink [1 hour]

    Visual Analog Scales (VAS) of alcohol craving total score in response to in vivo alcohol cues. Higher scores indicate greater craving severity with a minimum score of 0 and a maximum score of 80.

Secondary Outcome Measures

  1. Drinking [Up to 2 weeks]

    Number of standard drinks per week using the Timeline Followback Interview (TLFB). Total number of alcoholic drinks consumed per week with a minimum value of 0 and an undetermined maximum value.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male or female volunteers, 18-75 years of age.

  • Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity (AUD-MS).

  • Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues.

  • Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session.

  • In acceptable health in the judgment of the study physician, based on interview, medical history, physical exam, ECG, routine urine and blood chemistry.

  • Subjects with a history of depression, who have been on a stable dose of anti-depressant medication for at least 3 months, and do not meet current DSM-5 criteria for depression or anxiety.

  • All subjects must agree to use double barrier birth control for the study duration and one month thereafter i.e., males must use condoms and females must use spermicide and/or a non hormonal barrier method, and their opposite sex partner must likewise use an effective non hormonal form of contraception.

  • Able to provide informed consent and understand questionnaires and study procedures in English.

  • Willing to comply with the provisions of the protocol and take daily oral medication

Exclusion Criteria:

  • Medical conditions that could be aggravated by glucocorticoid and/or mineralocorticoid antagonism.

  • Clinically significant findings on physical exam, ECG, urine or blood tests that may increase risk.

  • CYP2C19 inhibitors

  • Substrates metabolized primarily by CYP3A, CYP2C9, and CYP2C8 with narrow therapeutic index

  • BCRP and UGT1A1 substrates

  • Meets DSM-5 criteria for a current major psychiatric disorder, including mood, anxiety or substance use disorders, other than alcohol, nicotine, or mild cannabis use disorders.

  • Pregnant or lactating.

  • Treatment within the month prior to screening with (1) an investigational drug, (2) drugs which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram [Antabuse], naltrexone [ReVia], acamprosate [Campral], or anticonvulsants.

  • Chronic systemic steroid use

  • Using drugs that are strong inhibitors and inducers of CYP2C9.

  • No fixed domicile and/or no availability by home or mobile telephone.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Scripps Research Institute Pearson Center for Alcoholism and Addiction Research La Jolla California United States 92037

Sponsors and Collaborators

  • The Scripps Research Institute
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Barbara J. Mason, Ph.D., The Scripps Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Scripps Research Institute
ClinicalTrials.gov Identifier:
NCT04466215
Other Study ID Numbers:
  • NIAAAMAS006420
  • U01AA025476
First Posted:
Jul 10, 2020
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Scripps Research Institute
Alcohol-Related Disorders
Additional relevant MeSH terms:
Alcoholism

Study Results

No Results Posted as of Jun 15, 2022