Alcohol Use DisorderPhase 1NCT03732248
Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders
A Phase 1 study testing Rapamycin in people with Alcohol Use Disorder and Alcohol Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Alcohol Dependence
- What is being tested?
- Rapamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2018to 20 Jan 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
- Conditions
- Alcohol Use Disorder, Alcohol Dependence
- Being tested
- Rapamycin, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called Sirolimus
Immunosuppressive drug
PlaceboDrug
Also called Sugar Pill
Inert drug
| Study group | Role | What they receive |
|---|---|---|
| Rapamycin (sirolimus) 15mg | Active comparator | Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. Receives: Drug: Rapamycin |
| Placebo | Placebo comparator | Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: At participant's last study visit, approximately 10-14 days.
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.
Measured: At participant's last study visit, approximately 10 days.
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.
Measured: At participant's last study visit, approximately 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start12 Jul 2018
- Primary completion20 Dec 2019
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Saladin, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732248
- Sponsor's protocol ID
- 00073523
- Status last verified
- Jan 2021
- First submitted
- 1 Nov 2018
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders: A Translational Clinical Neuroscience Pilot Investigation of a Novel Pharmacological Agent
- ClinicalTrials.gov ID
- NCT03732248
- Acronym / sponsor ID
- 00073523
- Conditions
- Alcohol Use Disorder, Alcohol Dependence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapamycin (sirolimus) 15mg | Active comparator | Drug: RapamycinRapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered in three 5mg oral capsules. This administration happens once during the first visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RapamycinAlso: SirolimusImmunosuppressive drug | Drug | Rapamycin (sirolimus) 15mg |
| PlaceboAlso: Sugar PillInert drug | Drug | Placebo |
Primary outcome
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.
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.
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.
3 secondary outcomes
Drinking Days Between Visit 2 and Visit 3
Time frame: At participant's last study visit, approximately 10-14 days.
Drinks Per Drinking Day Between Visit 2 and Visit 3
Time frame: At participant's last study visit, approximately 10 days.
Heavy Drinking Days Between Visit 2 and Visit 3
Time frame: At participant's last study visit, approximately 10 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Saladin, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rapamycin in people with Alcohol Use Disorder and Alcohol Dependence, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.