Medical University of South Carolina
Charleston, South Carolina, 29425, United States
NCT Number: NCT03732248
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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Notify Me18 year and older
All sexes
Interventional
Phase 1
Charleston, South Carolina, 29425, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Immunosuppressive drug
Other names: Sirolimus
Inert drug
Other names: Sugar Pill
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.
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.
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.
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.
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.
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.
Medical University of South Carolina
Other
Altering Memories That Increase Risk of Relapse in Alcohol Use Disorders: A Translational Clinical Neuroscience Pilot Investigation of a Novel Pharmacological Agent
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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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