Naltrexone in AUD Reward Drinkers

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT05028062
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • XR-NTX 380 mg, intramuscular injection — DRUG
    Two doses of 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.
  • Placebo intramuscular injection — DRUG
    Two doses of XR-NTX 380 mg, intramuscular injection.

Study Details

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.

Key Dates

Start date
Mar 7, 2022
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: XR-NTX 380 mg, intramuscular injection
    Subjects will receive an injection of XR-NTX 380 mg (4 mL) repeated once after 4 weeks.
  • Placebo Comparator: Inactive placebo intramuscular injection
    Subjects will receive a placebo injection repeated once after 4 weeks.

Primary Outcome Measure

Frequency of heavy drinking days by medication group (timeline follow back calendar). [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pennsylvania Center for Studies of AddictionPhiladelphiaPennsylvania19104
Timothy S. Pond, M.P.H.
[email protected]
215-746-1959
Rachel Weyl, BS
[email protected]
215-746-1902
Henry R. Kranzler, M.D. (PRINCIPAL_INVESTIGATOR)
Kyle Kampman, M.D. (SUB_INVESTIGATOR)
Corinde Wiers, Ph.D. (SUB_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
University of Pennsylvania Center for Studies of Addiction· Philadelphia, PA

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