Treatment for Alcoholism

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Pennsylvania Center for Studies of Addiction, Philadelphia, PA
Alcoholism+1 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Naltrexone in AUD Reward Drinkers

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Eligible Conditions

  • Alcoholism
  • Alcohol Use Disorders (AUD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Alcoholism

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Alcoholism. Measurement will happen over the course of 8 weeks.

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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Alcoholism

Trial Design

2 Treatment Groups

XR-NTX 380 mg, intramuscular injection
1 of 2
Inactive placebo intramuscular injection
1 of 2
Active Control
Non-Treatment Group

This trial requires 60 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Inactive placebo intramuscular injectionSubjects will receive a placebo injection repeated once after 4 weeks.
XR-NTX 380 mg, intramuscular injectionSubjects will receive an injection of XR-NTX 380 mg (4 mL) repeated once after 4 weeks.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 8 weeks for reporting.

Closest Location

University of Pennsylvania Center for Studies of Addiction - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.
Primarily a reward drinker [i.e., with a score of >22 on the reward subscale and a score of <14 on the relief subscale of the Inventory of Drinking Situations (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).

Patient Q&A Section

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Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Alcoholism by sharing your contact details with the study coordinator.