St. PETERsburg Pain and Alcohol Intervention With Naltrexone and Gabapentin

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

January 25, 2021

Primary Completion Date

November 16, 2021

Study Completion Date

December 15, 2021

Conditions
Chronic PainAlcohol Use, UnspecifiedHIV Infections
Interventions
DRUG

Low-dose naltrexone

4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.

DRUG

Gabapentin

Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).

DRUG

Placebo

In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.

Trial Locations (1)

Unknown

First St. Petersburg Pavlov State Medical University, Saint Petersburg

Sponsors
All Listed Sponsors
collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

lead

Boston Medical Center

OTHER