Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders

NCT ID: NCT03732248

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2020-01-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rapamycin (sirolimus) 15mg

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

Group Type: ACTIVE_COMPARATOR

Rapamycin

Intervention Type: DRUG

Immunosuppressive drug

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inert drug

Interventions

Rapamycin

Immunosuppressive drug

Intervention Type: DRUG

Placebo

Inert drug

Intervention Type: DRUG

Other Intervention Names

Sirolimus; Sugar Pill

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Saladin, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00073523

Identifier Type: -

Identifier Source: org_study_id