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Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders

Primary Purpose

Alcohol Use Disorder, Alcohol Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rapamycin
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rapamycin (sirolimus) 15mg

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
November 1, 2018
Last Updated
January 7, 2021
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03732248
Brief Title
Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders
Official Title
Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders: A Translational Clinical Neuroscience Pilot Investigation of a Novel Pharmacological Agent
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
January 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rapamycin (sirolimus) 15mg
Arm Type
Active Comparator
Arm Description
Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
Intervention Type
Drug
Intervention Name(s)
Rapamycin
Other Intervention Name(s)
Sirolimus
Intervention Description
Immunosuppressive drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar Pill
Intervention Description
Inert drug
Primary Outcome Measure Information:
Title
Evaluate Safety of a Single 15 mg Dose of Rapamycin (Sirolimus) at First Visit.
Description
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.
Time Frame
MOSES will be assessed at the first study visit on day 1.
Title
Evaluate Safety of Rapamycin (Sirolimus) at Second Visit.
Description
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.
Time Frame
MOSES will be assessed at the second study visit, 24 hours after medication administration.
Title
Evaluate Safety of Rapamycin (Sirolimus) at Third (Last) Visit.
Description
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.
Time Frame
MOSES will be assessed at the third study visit, approximately 10 days after medication administration.
Secondary Outcome Measure Information:
Title
Drinking Days Between Visit 2 and Visit 3
Description
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.
Time Frame
At participant's last study visit, approximately 10-14 days.
Title
Drinks Per Drinking Day Between Visit 2 and Visit 3
Description
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.
Time Frame
At participant's last study visit, approximately 10 days.
Title
Heavy Drinking Days Between Visit 2 and Visit 3
Description
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.
Time Frame
At participant's last study visit, approximately 10 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Saladin, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders

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