Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care

NCT01893827 | Completed Phase 4 Results

• 1 other identifier: 12-02263
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is a pragmatic, randomized, open-label clinical trial of 24 weeks of XR-NTX vs. O-NTX using a COMBINE-adapted Medical Management primary care treatment model. 237 adults \>18yo with alcohol dependence will be recruited from the community into treatment in public sector primary care settings. The primary outcome which powers this study is a dichotomous good clinical outcome defined by abstinence or moderate drinking, and as measured by the Timeline Follow-back and analyzed using an intention-to-treat approach among all randomized participants. Secondary outcomes include the incremental cost effectiveness of the two arms, differences between arms by continuous measures of alcohol intake (drinks/day, % days abstinent, time to first heavy drinking day, bio-markers), and the exploratory analysis of factors possibly associated with effectiveness, including gender, prior treatment abstinence, and mu opioid receptor (OPRM1) genotypes. Specific Aim 1: Treatment Effectiveness. To evaluate the effectiveness of extended-release naltrexone (XR-NTX) vs. oral naltrexone (O-NTX) in producing a primary good clinical outcome, defined as abstinence or moderate drinking (≤2 drinks/day, men; ≤1 drink/day,women; and ≤2 heavy drinking occasions/month), during the final 20 of 24 weeks of primary care-based Medical Management for alcohol dependence. Hypothesis: The rate of this good clinical outcome will be approximately twice as great among participants receiving XR-NTX compared with those receiving O-NTX. Specific Aim 2: Cost Effectiveness. To estimate the incremental cost effectiveness of XR-NTX vs. O-NTX,both in conjunction with primary care-based Medical Management. Hypothesis: XR-NTX treatment will be more cost effective than O-NTX. Specific Aim 3: Patient-Level Predictors of Effectiveness. To identify patient-level characteristics associated with effectiveness in both arms.

Conditions

Alcohol Dependence

Keywords

Naltrexone; Extended-release naltrexone; Oral naltrexone; Vivitrol; XR-NTX; alcohol dependence; primary care; Medical Management

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Alcohol Abstinence or Moderate Drinking

  Percentage of participants who had the following number of drinks (≤2 drinks/day, men; ≤1 drink/day, women; and ≤2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management for alcohol dependence.

  4-24 weeks

Other Outcomes (2)

• Cost-effectiveness

  0-24 weeks

• Patient-level Predictors of Effectiveness

  4-24 weeks

Study Arms (2)

XR-NTX

ACTIVE COMPARATOR

Xr-NTX 380mg IM injection monthly x 6 months

Drug: XR-NTX (Extended-Release Naltrexone)

Oral Naltrexone

ACTIVE COMPARATOR

Oral naltrexone 50mg/day x 6 months

Drug: Oral Naltrexone (O-NTX)

Interventions

XR-NTX (Extended-Release Naltrexone) DRUG

380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.

Also known as: Vivitrol

XR-NTX

Oral Naltrexone (O-NTX) DRUG

50mg pill form of naltrexone taken 1x/day for 6 months.

Also known as: Revia

Oral Naltrexone

Eligibility Criteria

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

You may qualify if:

• Adults, age ≥18 y.o.
• English- or Spanish- speaking and able to understand study procedures and provide full consent.
• DSM IV diagnosis of alcohol dependence as determined by study physician and DSM IV checklist.
• Endorses goal of abstinence, and is able to achieve alcohol abstinence without inpatient detoxification, per study physician.

You may not qualify if:

• Current opioid dependence and/or positive urine toxicology for extended opioids.
• Pregnancy or female planning conception.
• Allergy to naltrexone or the PGL XR-NTX formulation or diluent.
• Severe liver disease, liver failure, or liver function test levels greater than three times normal.
• Other severe, untreated or uncontrolled medical illness (e.g., severe heart failure or dementia).

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

vivitrol; Naltrexone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Mia Malone
• Organization: NYU Langone Health

mia.malone@nyulangone.org

646-501-3577

Study Officials

• Joshua D. Lee, MD, MSc

  NYU School of Medicine, Dept. Population Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 9, 2013
• Study Start: June 1, 2014
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Locations

US (1)