Clinical trial

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide

Recruiting now · Phase 2 · 1 countries · Registry ID NCT07040592

Recruiting nowPhase 2Interventional

What this study is about

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionAlcohol Use Disorder (AUD), HIV

Full registry criteria

Inclusion Criteria: * diagnosed with HIV * Receive care at the Atlanta VA Healthcare System * Age 18 or over * Meet criteria for mild, moderate, or severe alcohol use disorder by the DSM-5 Alcohol Symptom Checklist and the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) screen * Have evidence of significant alcohol use: PEth \> 20ng/ml * Prescribed \>=5 medications * Have cell phone or reliable contact number * Can provide written informed consent Exclusion Criteria: * Active engagement in formal alcohol treatment including medications for alcohol use disorder at the time of enrollment * Self-report or laboratory test confirming pregnancy, nursing, or trying to conceive * Life-threatening or unstable medical, surgical, or psychiatric condition that prohibits participation (including current or past intent to harm oneself or others within the prior 12 months and not receiving treatment) * Untreated moderate to severe opioid use disorder * Residence out of state * Inability to read or understand English * History of serious hypersensitivity or adverse reaction to study medication * Taking potentially interactive medication(s) for diabetes * BMI\<23 * Diagnosis of type 1 Diabetes * Personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, Severe gastrointestinal dysmotility, including gastroparesis, History of pancreatitis (does not pertain to patients for whom the cause of pancreatitis is known and no longer presents a risk), severe gallbladder disease * Known Proliferative Diabetic Retinopathy, severe Non-Proliferative Diabetic Retinopathy, clinically significant Macular Edema, or Cystoid Macular Edema * Already prescribed the pilot medication at the time of study recruitment.

Treatments and study arms

semaglutide

Drug

All participants will receive a prescription for semaglutide and will meet with a clinical pharmacist and addiction psychiatrist for further support

Primary outcomes

Proportion of participants who complete enrollment and duration of sessions12 weeks

Proportion of participants who complete enrollment and duration of sessions to assess feasibility of study

Number of sessions completed12 weeks

Number of sessions completed to assess acceptability of study

Adherence to Medication12 weeks

Medication adherence will be measured by the number of prescriptions filled by electronic health record to assess acceptability of study

Safety of study assessed by adverse event reporting12 weeks

Safety will be assessed by the percentage of study participants who report adverse events.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Atlanta VA Medical Center🇺🇸 Decatur, Georgia, United States
Ketteria IngramContact
Vincent Marconi, MDPrincipal Investigator