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OpenTrials
Completed

NCT Number: NCT03732248

Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rapamycin

Drug

Immunosuppressive drug

Other names: Sirolimus

Placebo

Drug

Inert drug

Other names: Sugar Pill

Primary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

Secondary outcomes

  1. Drinking Days Between Visit 2 and Visit 3

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

    Participants will be given a timeline to record any drinking that occurs between visits 2 and 3.

    Time line follow back procedures were used to record daily drinking behavior for all study days; recorded as standard drinks. The total number of days where drinking was recorded is summed for each participants during the study window.

  2. Drinks Per Drinking Day Between Visit 2 and Visit 3

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

    Participants will be given a timeline to record any drinking that occurs between visits 2 and 3.

    Time line follow back procedures were used to record daily drinking behavior for all study days; recorded as standard drinks.

  3. Heavy Drinking Days Between Visit 2 and Visit 3

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

    Participants will be given a timeline to record any drinking that occurs between visits 2 and 3.

    Time line follow back procedures were used to record daily drinking behavior for all study days; recorded as standard drinks. Heavy drinking days are defined as >=5 drinks per day for Males and >=4 drinks per day for Females.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Nov 6, 2018
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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