Naltrexone in AUD Reward Drinkers

NCT05028062 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 849558
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase IV, two-arm, randomized, double-blind, placebo-controlled study to assess whether individuals identified as primarily reward drinkers are significantly more likely to reduce heavy drinking if they receive XR-NTX than a matching placebo injection. Study subjects will receive monthly injections of long-acting injectable naltrexone 380 mg (4 mL) or matching placebo. All subjects will also receive 4 sessions of Medical Management (MM). Post-treatment follow-up visits will be conducted at 4 weeks after the scheduled completion of treatment.

Conditions

Alcohol Use Disorder; Alcoholism

Keywords

XR-NTX; Naltrexone; Alcohol

Outcome Measures

Primary Outcomes (1)

• Frequency of heavy drinking days by medication group (timeline follow back calendar).

  The number of Heavy Drinking Days during 8 weeks of treatment in the Naltrexone and placebo groups.

  8 weeks

Secondary Outcomes (1)

• Frequency of drinking days, and drinks/drinking day by medication group (timeline follow back calendar).

  8 weeks

Study Arms (2)

XR-NTX 380 mg, intramuscular injection

ACTIVE COMPARATOR

Subjects will receive an injection of XR-NTX 380 mg (4 mL) repeated once after 4 weeks.

Drug: XR-NTX 380 mg, intramuscular injection; Behavioral: Medical Management

Inactive placebo intramuscular injection

PLACEBO COMPARATOR

Subjects will receive a placebo injection repeated once after 4 weeks.

Behavioral: Medical Management; Drug: Placebo intramuscular injection

Interventions

XR-NTX 380 mg, intramuscular injection DRUG

Two doses of XR-NTX 380 mg, intramuscular injection.

Also known as: Vivitrol naltrexone for extended-release injectable suspension

XR-NTX 380 mg, intramuscular injection

Medical Management BEHAVIORAL

All subjects will receive 8 weeks of medical management (Pettinati et al. 2004) will support subjects' efforts to reduce or stop their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the subject's drinking, and make recommendations to follow until the next visit. Men will be advised to consume no more than 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week.

Inactive placebo intramuscular injection; XR-NTX 380 mg, intramuscular injection

Placebo intramuscular injection DRUG

Two doses of XR-NTX 380 mg, intramuscular injection.

Also known as: Inactive placebo

Inactive placebo intramuscular injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• Alkermes, Inc.: collaborator

Study Sites (1)

University of Pennsylvania Center for Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Injections, Intramuscular; Practice Management, Medical

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Henry R Kranzler, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy S Pond, MPH

CONTACT

215-746-1959; timpond@pennmedicine.upenn.edu

Rachel Weyl, BS

CONTACT

215-746-1902; rachel.weyl@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled, parallel-group clinical trial

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: August 31, 2021
• Study Start: March 7, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)