Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders



Status:Recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:11/8/2018
Start Date:July 12, 2018
End Date:June 2019
Contact:Emily Burns
Email:burnsemi@musc.edu
Phone:843-792-6984

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Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders: A Translational Clinical Neuroscience Pilot Investigation of a Novel Pharmacological Agent

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.


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)
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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