RECRUITING

Pregnenolone for the Treatment of Alcohol Use Disorder

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Conditions

Alcohol Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d dosing) vs. placebo (PBO) over a 12 week treatment period, and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder (AUD).

Official Title

Pregnenolone for the Treatment of Alcohol Use Disorder

Quick Facts

Study Start:2024-01-08
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05781009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female individuals, ages 18 to 70.
  2. * Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for alcohol use disorder; documented positive urine toxicology screen for alcohol at intake or collateral information from family members, significant others, room-mates etc., on recent use.
  3. * Subject has voluntarily given informed consent and signed the informed consent document.
  4. * Able to read English and complete study evaluations.
  1. * Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
  2. * Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/Phencyclidine (PCP), excluding alcohol and nicotine.
  3. * Any current use of opiates or past history of opiate use disorder (assessed via urine toxicology and self report).
  4. * Current use of any psychoactive drugs (urine toxicology), including anxiolytics, naltrexone or antabuse.
  5. * Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention.
  6. * Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
  7. * Hypotensive individuals with sitting blood pressure below 90/50 mmHG.

Contacts and Locations

Study Contact

Verica Milivojevic, PhD
CONTACT
203-737-1176
verica.milivojevic@yale.edu
Rajita Sinha, PHD
CONTACT
203-737-5805
rajita.sinha@yale.edu

Study Locations (Sites)

The Yale Stress Center: Yale University
New Haven, Connecticut, 06519
United States

Collaborators and Investigators

Sponsor: Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-08
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2024-01-08
Study Completion Date2028-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Alcohol Use Disorder