Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders

NCT03732248 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 00073523
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the effects of rapamycin (sirolimus) versus a placebo, an inactive substance, on responses to alcohol cues in individuals with alcohol use disorder. Rapamycin (sirolimus) is a FDA-approved antibiotic and immunosuppressive drug that is currently used to (a) prevent organ transplant recipients from rejecting their transplants (b) treat cardiovascular diseases, and (c) treat some forms of cancer. Rapamycin (sirolimus) is not FDA-approved to treat alcohol use disorder. The use of rapamycin (sirolimus) in this study is investigational, meaning that the study medication is not a proven treatment for alcohol use disorder. The study will examine the medication's use as a potential treatment for alcohol use disorder, as well as how safe and tolerable it is to take.

Conditions

Alcohol Use Disorder; Alcohol Dependence

Outcome Measures

Primary Outcomes (3)

• Evaluate Safety of a Single 15 mg Dose of Rapamycin (Sirolimus) at First Visit.

  Safety will be monitored through adverse events checks by the study physician assistant (PA). The study PA will use the Monitoring of Side-Effects Scale (MOSES) to track if there are any adverse effects. Participants will be recorded as those who report any adverse event vs. no adverse events.

  MOSES will be assessed at the first study visit on day 1.

• Evaluate Safety of Rapamycin (Sirolimus) at Second Visit.

  Safety will be monitored through adverse events checks by the study physician assistant (PA). The study PA will use the Monitoring of Side-Effects Scale (MOSES) to track if there are any adverse effects. Participants will be recorded as those who report any adverse event vs. no adverse events.

  MOSES will be assessed at the second study visit, 24 hours after medication administration.

• Evaluate Safety of Rapamycin (Sirolimus) at Third (Last) Visit.

  Safety will be monitored through adverse events checks by the study physician assistant (PA). The study PA will use the Monitoring of Side-Effects Scale (MOSES) to track if there are any adverse effects. Participants will be recorded as those who report any adverse event vs. no adverse events.

  MOSES will be assessed at the third study visit, approximately 10 days after medication administration.

Secondary Outcomes (3)

• Drinking Days Between Visit 2 and Visit 3

  At participant's last study visit, approximately 10-14 days.

• Drinks Per Drinking Day Between Visit 2 and Visit 3

  At participant's last study visit, approximately 10 days.

• Heavy Drinking Days Between Visit 2 and Visit 3

  At participant's last study visit, approximately 10 days.

Study Arms (2)

Rapamycin (sirolimus) 15mg

ACTIVE COMPARATOR

Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.

Drug: Rapamycin

Placebo

PLACEBO COMPARATOR

Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.

Drug: Placebo

Interventions

Rapamycin DRUG

Immunosuppressive drug

Also known as: Sirolimus

Rapamycin (sirolimus) 15mg

Placebo DRUG

Inert drug

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be treatment-seekers
• Meet criteria for alcohol use disorder
• Must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments
• Must use one of the following methods of birth control: oral contraceptives, barrier methods (diaphragm or condoms with spermicide or both), surgical sterilization, use of an intra-uterine contraceptive device, or complete abstinence from sexual intercourse
• Must live within a 50-mile radius of our research program and have reliable transportation,
• Must consent to remain abstinent from alcohol and all non-prescription drugs prior to medication administration and testing sessions
• Must consent to fast for a two-hour period prior to medication administration
• Must consent to random assignment to the rapamycin vs. placebo conditions.

You may not qualify if:

• Cannot be undergoing other alcohol cessation treatment
• Cannot be pregnant, nursing, or of childbearing potential and not using birth control
• Cannot have evidence of or a history of significant endocrine, cardiovascular, pulmonary, renal, or neurological disease
• Cannot have significant liver impairment
• Cannot have an existing infection or immune system disorder
• Cannot have a history of or current psychotic disorder, severe major depression, or bipolar affective disorder
• Cannot currently take anti-arrythmic agents, psychostimulants, or any other agents known to interfere with heart rate and skin conductance monitoring
• Cannot have known or suspected hypersensitivity to macrolide compounds (such as rapamycin/sirolimus)
• Cannot currently take medications that could adversely interact with the study medication, including but not limited to significant inhibitors of CYP2D6 or CYP3A4 (voriconazole, fluconazole, itraconazole, erythromycin, clarithromycin, diltiazem, verapamil, etc.), or significant inducers of CYP3A4, such as anticonvulsants (carbamazepine, phenobarbital, phenytoin, etc.) and antibiotics (rifabutin, rifapentine, etc.)
• Cannot have a history of thrombocytopenia, idiopathic thrombocytopenia purpura (ITP) or have a platelet count of less than 100,000 cells per mm3
• Cannot have any unhealed wounds
• Cannot have any planned surgeries within the next month, including surgical dental procedures
• Cannot have a history of complicated alcohol withdrawal symptoms (including, but not limited to, symptoms such as seizures, hallucinations, and high blood pressure)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Sirolimus; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: Dr. Michael Saladin
• Organization: Medical University of South Carolina

saladinm@musc.edu

843-792-5306

Study Officials

• Michael Saladin, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 6, 2018
• Study Start: July 12, 2018
• Primary Completion: December 20, 2019
• Study Completion: January 20, 2020
• Last Updated: January 27, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)