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Extended-Release vs. Oral Naltrexone Alcohol Treatment in Primary Care (X-ON)

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ClinicalTrials.gov Identifier: NCT01893827
Recruitment Status : Active, not recruiting
First Posted : July 9, 2013
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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. 234 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; <1drink/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.


Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: XR-NTX (Extended-Release Naltrexone) Drug: Oral Naltrexone (O-NTX) Phase 4

Detailed Description:

Rationale: Though integration of alcohol pharmacotherapy into primary care settings is receiving increasing emphasis and support, rigorous data to inform clinicians' treatment choice is lacking. The most recently FDA-approved alcohol treatment medication, an extended-release depot form of naltrexone (XR-NTX, Vivitrol®), could greatly simplify the medical home-centered alcohol treatment emphasized in the National Institute on Alcohol Abuse and Alcoholism (NIAAA) Clinician's Guide. Injected once a month, XR-NTX offers a long-acting and thus potentially more effective form of pharmacotherapy than oral naltrexone (O-NTX), which, despite the Combined Pharmacotherapies and Behavioral Interventions for Alcohol Dependence (COMBINE) trial and systematic reviews supporting some efficacy, has been characterized by low rates of overall prescribing, poor adherence, suboptimal monthly refill and inadequate treatment retention. Yet while promising as an alternative to O-NTX, XR-NTX is substantially more expensive (~$1100 vs. ~$100 per month), and no head-to-head trials have compared the two forms of naltrexone. A comparative effectiveness approach is required to systematically evaluate the following key questions: In primary care settings, what is the relative clinical effectiveness of XR-NTX vs. O-NTX? What are the benefits and costs of XR-NTX relative to O-NTX? And can patient and system characteristics be identified to inform treatment choice to maximize the probability of successful outcome?

Implications: Despite several years of experience, the comparative effectiveness of XR-NTX compared to older alcohol medications remains uncertain, particularly in a mainstream, primary care treatment model that is generalizable and broadly accessible. Newer, novel, expensive medications for addiction disorders are historically greatly underutilized by primary care physicians. This study is innovative both as a 'head-to-head' evaluation of XR-NTX vs. O-NTX in primary care, and because expected participants will be primarily Medicaid-covered or uninsured persons who will not be excluded based on medical and psychiatric co-morbidities that often preclude participation in efficacy studies. If health insurance expansion, parity reforms, medical homes and accountable care organizations are to define primary care as a core alcohol treatment setting in the coming decade, exactly this type of study is required to guide treatment protocols and resource allocation. Ultimately, more widespread adoption of cost-effective alcohol pharmacotherapies will result in longer,healthier lives and lower costs.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Open-label Clinical Trial of Extended-Release vs. Oral Naltrexone for Alcohol Treatment in Primary Care.
Actual Study Start Date : June 2014
Estimated Primary Completion Date : September 12, 2019
Estimated Study Completion Date : September 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: XR-NTX
Xr-NTX 380mg IM injection monthly x 6 months
Drug: XR-NTX (Extended-Release Naltrexone)
380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.
Other Name: Vivitrol

Active Comparator: Oral Naltrexone
Oral naltrexone 50mg/day x 6 months
Drug: Oral Naltrexone (O-NTX)
50mg pill form of naltrexone taken 1x/day for 6 months.
Other Name: Revia




Primary Outcome Measures :
  1. Good Clinical Outcome (alcohol abstinence or moderate drinking only) [ Time Frame: 4-24 weeks ]
    Number of drinks (<2 drinks/day, men; <1drink/day, women; and <2 heavy drinking occasions/month) during the final 20 of 24 weeks of primary care-based Medical Management for alcohol dependence.


Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 0-24 weeks ]
    To estimate the incremental cost-effectiveness of XR-NTX vs. O-NTX, both in conjunction with primary care-based medical management. Economic data will be derived primarily from the Economic Form 90, Non-Study Medical Service and electronic medical records assessments, EQ-5D (functional status), and a cost survey or standardized question querying patient reports of specific non-medical related costs (including lost/gained work, lost/gained dependent care, transportation costs, arrests, motor vehicle accidents) collected at baseline and at week 10, 18, 26, and 48 assessments.


Other Outcome Measures:
  1. Patient-level predictors of effectiveness [ Time Frame: 4-24 weeks ]
    To identify patient-level characteristics (gender, ethnicity, pre-treatment abstinence, voluntary specialty alcohol treatment and Alcoholics Anonymous involvement) associated with effectiveness in both arms. Baseline Demographic and Timeline Follow-Back and in-study Non-Study Medical Service questionnaires will characterized these patient-level variables.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01893827


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Joshua D. Lee, MD, MSc NYU School of Medicine, Dept. Population Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01893827     History of Changes
Other Study ID Numbers: 12-02263
First Posted: July 9, 2013    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Keywords provided by NYU Langone Health:
Naltrexone
Extended-release naltrexone
Oral naltrexone
Vivitrol
XR-NTX
alcohol dependence
primary care
Medical Management
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Naltrexone
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Alcohol Deterrents
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents