Naltrexone treatment for heavy drinkers with Alcohol Use Disorder
Testing the Reward-Drinker Hypothesis of Naltrexone Using an Extended-Release Formulation
This study is testing if a long-acting injection of naltrexone can help heavy drinkers cut back on their alcohol use.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05028062 on ClinicalTrials.gov |
What this trial studies
This phase IV clinical trial evaluates the effectiveness of long-acting injectable naltrexone in reducing heavy drinking among individuals identified as primarily reward drinkers. Participants will be randomly assigned to receive either the naltrexone injection or a placebo, alongside four sessions of Medical Management. The study includes a thorough screening process to ensure participant eligibility and safety, with follow-up visits scheduled four weeks after treatment completion to assess outcomes. The trial aims to determine if naltrexone can significantly decrease alcohol consumption in this specific population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a DSM-5 diagnosis of Alcohol Use Disorder who consume a high volume of alcohol weekly and express a desire to reduce or stop drinking.
Not a fit: Patients who do not meet the eligibility criteria, such as those with lower alcohol consumption or those not willing to commit to the study procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to significant reductions in heavy drinking and improved outcomes for individuals with Alcohol Use Disorder.
How similar studies have performed: Previous studies have shown promise in using naltrexone for treating Alcohol Use Disorder, indicating that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-65 years old * Willing to provide signed, informed consent and commit to completing the study procedures * Able to read at an 8th grade or higher level * Current DSM-5 diagnosis of AUD * Reports consuming 24+ standard drinks (men) or 18+ standard drinks (women) weekly on average over the month prior to consent * Expresses a desire to reduce or stop drinking and a willingness to receive two injections of study medication over 8 weeks of treatment. * Either a reward drinker \[i.e., an individual with a score of 19 or greater on the reward subscale and less than or equal to 18 on the relief subscale of the Inventory of Drinking Situations (IDS)\] or a relief drinker (i.e., an individual with a score of 21 or greater on the relief subscale and less than or equal to 18 on the reward subscale of the IDS). * Has a stable address in the local area; not planning to move; has documents for an ID check * Women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or are less than two years postmenopausal): must be non-lactating and practicing a reliable method of birth control and have a negative urine pregnancy test prior to the initiation of the study procedures. Examples of medically acceptable methods for this protocol include oral contraceptive pills, intrauterine device, injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm/spermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence). Exclusion Criteria: * Planned surgery within the timeframe of the study * A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that could interfere with study participation or make it hazardous for the subject to do so (e.g., bleeding disorder, pancreatitis, epilepsy, diabetes, liver disease, kidney disease, or cardiomyopathy as determined by history and clinical exam); ALAT or ASAT concentration greater than 3 times the upper limit of normal (ULN), or direct bilirubin above the ULN. (Note-abnormal laboratory tests during screening may be repeated once). * Chronic or episodic painful conditions that could require opioid medications for pain control * History of seizure disorder (excluding childhood febrile seizures) * History of allergy or other serious adverse event due to treatment with XR-NTX * Current psychotic disorder (bipolar, schizophrenia, major depression with suicidal ideation, or psychotic features) identified by clinical examination or the structured interview that could interfere with study participation or make it hazardous for the subject. * Current DSM-5 diagnosis of any drug use disorder other than alcohol, nicotine, or cannabis or a urine drug screen that is positive for benzodiazepines, opioids, amphetamines, cocaine or barbiturates. * Current treatment with a psychotropic, anticonvulsant, opioid, anticoagulant or AUD treatment medication (i.e., naltrexone, acamprosate, disulfiram, topiramate, gabapentin, varenicline, or baclofen) * Receipt of any experimental medication within the past 30 days * In need of medical detoxification from alcohol * Subjects cannot have been mandated by court for alcohol or drug abuse treatment or have pending legal proceedings that could result in incarceration within 6 months of enrollment. * Homicidal or other behavioral disturbance that requires immediate clinical attention * Judged by the principal investigator or his designee to be an unsuitable candidate for study participation
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania Center for Studies of Addiction — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Henry R Kranzler, MD — University of Pennsylvania
- Study coordinator: Timothy S Pond, MPH
- Email: timpond@pennmedicine.upenn.edu
- Phone: 215-746-1959
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.