CLINICAL TRIALS PROFILE FOR VIVITROL

All Clinical Trials for VIVITROL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00156923 ↗	ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults	Completed	Alkermes, Inc.	Phase 3	2003-10-01	This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).
NCT00156936 ↗	ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])	Terminated	Alkermes, Inc.	Phase 3	2004-08-01	This was a multicenter extension of Alkermes' Study ALK21-006 (NCT01218997) designed to assess the long-term safety of repeat monthly doses of naltrexone long-acting injection. All subjects received open-label Medisorb® naltrexone 380 mg (VIVITROL®). Planned treatment duration was up to 3 years. Alkermes terminated the study for business purposes in December 2006. The median duration of treatment among all subjects in this extension study was 43 weeks.
NCT00338962 ↗	Naltrexone & SSRI in Alcoholics With Depression/PTSD	Completed	Yale University	Phase 3	2001-10-01	The purpose of this study is to evaluate the efficacy of naltrexone in combination with an SSRI to reduce alcohol consumption in alcoholic patients with comorbid PTSD and depression. We hypothesize that the combination of naltrexone and SSRI will exhibit a greater decrease in alcohol consumption than that seen with treatment with SSRI alone, or with a combination of another class of antidepressant and naltrexone. We also hypothesize that SSRI will be effective in treating PTSD and depressive symptoms and naltrexone will be well tolerated.
NCT00476242 ↗	Memantine as a Supplement to Naltrexone in Treating Heroin Dependence	Completed	National Institute on Drug Abuse (NIDA)	Phase 2/Phase 3	2008-06-01	Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also consist of 3 weekly visits to the clinic in which patients will receive counseling to help maintain abstinence and improve compliance with study medication.
NCT00476242 ↗	Memantine as a Supplement to Naltrexone in Treating Heroin Dependence	Completed	New York State Psychiatric Institute	Phase 2/Phase 3	2008-06-01	Prospective participants will undergo a screening process at the clinic to determine eligibility. After screening, eligible patients will complete an 8-day inpatient detoxification, followed by a 12-week outpatient phase. Patients will be randomly assigned to one of two conditions (1) Naltrexone + Placebo; (2) Naltrexone + Memantine 20 mg bid. Long-acting, injectable form of naltrexone (Vivitrol) will be administered once per month (the total of three injections) while memantine or placebo will be taken daily. In addition, patients will receive twice weekly psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The outpatient treatment will also consist of 3 weekly visits to the clinic in which patients will receive counseling to help maintain abstinence and improve compliance with study medication.
NCT00501631 ↗	ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence	Completed	Alkermes, Inc.	Phase 3	2007-07-01	VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.
NCT00511836 ↗	ALK21-018: Effects of Medisorb® Naltrexone (VIVITROL®) on Alcohol Craving in Treatment-seeking, Alcohol-dependent Adults	Completed	Alkermes, Inc.	Phase 4	2007-07-01	This was a study of the effects of VIVITROL® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence. The study was powered to to detect whether VIVITROL attenuates or blocks the BOLD signal increases in response to alcohol-related cues. In the double-blind portion, subjects received a single administration of study drug (VIVITROL 380 mg or placebo). Subjects who completed the double-blind portion could opt to continue to the open-label portion and receive 2 additional months of treatment with VIVITROL 380 mg.

Clinical Trial Conditions for VIVITROL

Condition Name

Condition Name for VIVITROL
Intervention	Trials
Alcohol Dependence	12
Opiate Dependence	11
Opioid Dependence	11
Opioid-use Disorder	10

Condition MeSH

Condition MeSH for VIVITROL
Intervention	Trials
Opioid-Related Disorders	47
Alcoholism	25
Substance-Related Disorders	12
Disease	11

Clinical Trial Locations for VIVITROL

Trials by Country

Trials by Country for VIVITROL
Location	Trials
United States	138
Norway	6
Russian Federation	3
Canada	2
Iceland	1

Trials by US State

Trials by US State for VIVITROL
Location	Trials
New York	26
California	12
Maryland	9
Pennsylvania	9
Texas	7

Clinical Trial Progress for VIVITROL

Clinical Trial Phase

Clinical Trial Phase for VIVITROL
Clinical Trial Phase	Trials
PHASE3	1
PHASE1	2
Phase 4	19

Clinical Trial Status

Clinical Trial Status for VIVITROL
Clinical Trial Phase	Trials
Completed	58
Recruiting	10
Not yet recruiting	10

Clinical Trial Sponsors for VIVITROL

Sponsor Name

Sponsor Name for VIVITROL
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	33
Alkermes, Inc.	24
New York State Psychiatric Institute	13

Sponsor Type

Sponsor Type for VIVITROL
Sponsor	Trials
Other	118
Industry	40
NIH	39

Vivitrol (naltrexone) Clinical Trials, Market Status and Projections

Last updated: February 3, 2026

Overview

Vivitrol (naltrexone for extended-release injectable suspension) is an opioid antagonist used primarily in treating opioid dependence and alcohol dependence. Its mechanism involves blocking opioid receptors, preventing the euphoric effects of opioids and reducing alcohol cravings. Approved by the FDA in 2010 for alcohol dependence and in 2010 for opioid dependence, Vivitrol remains a focal point in addiction therapy markets.

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What Are the Latest Developments in Vivitrol’s Clinical Trials?

Recent clinical efforts center on expanding indications, optimizing delivery methods, and comparing efficacy with newer therapies.

Ongoing and Completed Trials:

• Alcohol Use Disorder (AUD): Multiple studies evaluate Vivitrol's effectiveness in reducing alcohol consumption among diverse populations. Recent phase 4 trials focus on long-term efficacy and safety over 12-24 months.

• Opioid Dependence: Trials explore Vivitrol's role in managing opioid use disorder (OUD), particularly in conjunction with behavioral therapies and medication-assisted treatments (MAT).

• Extended-release Formulations: Trials assess new delivery platforms such as biodegradable implants and novel microsphere formulations to enhance compliance and reduce injection frequency.

• Comorbidity Focus: Studies on Vivitrol's effectiveness in patients with co-occurring mental health conditions, such as depression or PTSD, are ongoing.

Key Trial Outcomes:

• Vivitrol consistently reduces relapse rates for alcohol and opioid dependence.
• Safety profiles remain stable, with common adverse events including injection site reactions, nausea, and fatigue.
• Long-term data support sustained abstinence, with some studies noting reductions in cravings lasting beyond treatment periods.

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Market Analysis of Vivitrol

Market Overview and Market Share:

The Vivitrol market has expanded significantly since its 2010 approval, driven by escalating opioid overdose rates and increased acceptance of medication-assisted treatment (MAT).

• Global Market Size (2022): Estimated at USD 950 million, with the U.S. accounting for approximately 75% of revenue.

• Market Penetration: Vivitrol holds an estimated 20-25% of the opioid dependence treatment market in the U.S., competing with oral naltrexone, buprenorphine, and methadone.

• Pricing and Reimbursement: The average wholesale price per injection hovers around USD 1,200-1,500. Payer coverage has improved through increased Medicaid and private insurer reimbursement, although high costs limit access in some regions.

Competitive Landscape:

• Oral Naltrexone: Lower cost but limited adherence.
• Buprenorphine: Higher market share due to ease of use and broader provider familiarity.
• Methadone: Widely used in specialized clinics, with lower treatment costs but regulatory burdens.

Key Challenges:

• Cost barriers impede wider adoption.
• Limited awareness among prescribers outside specialized addiction centers.
• Preference for alternative therapies, especially in outpatient settings.

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Market Projections for the Coming Years

Growth Drivers:

• Rising overdose deaths from opioids fuel demand for effective treatments.
• Increased insurance coverage and regulatory support.
• Expanded indications, including potential use for relapse prevention in other substance use disorders.

Forecasts (2023-2028):

Year	Estimated Market Size (USD)	Compound Annual Growth Rate (CAGR)
2023	USD 1.0 billion	8%
2024	USD 1.1 billion	10%
2025	USD 1.2 billion	9%
2026	USD 1.3 billion	8%
2027	USD 1.4 billion	7%
2028	USD 1.5 billion	6%

Factors Influencing Growth:

• Emerging evidence supports broader indications, including relapse prevention in other substance disorders.
• Innovation in delivery systems improving adherence.
• Policy reforms favoring MAT in correctional and community health programs.

Potential Limitations:

• Price competition from biosimilars or generics for oral naltrexone.
• Regulatory delays or restrictions.
• Changes in reimbursement policies affecting uptake.

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Key Takeaways

• Vivitrol’s clinical trials reinforce its efficacy in reducing relapse for alcohol and opioid dependence.
• The drug holds a sizable market share in the treatment of opioid use disorder but faces competition and cost barriers.
• The market is projected to grow at a CAGR of approximately 8-10%, driven by overdose crises and expanding indications.
• Innovations in delivery mechanisms and broader policy acceptance could further catalyze growth.
• Market expansion remains contingent on addressing affordability and enhancing prescriber awareness.

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FAQs

1. Are there ongoing trials for new indications of Vivitrol?
Yes. Current trials explore Vivitrol's application in preventing relapse in other substance use disorders, such as cocaine dependence, and in co-occurring mental health conditions.

2. How does the efficacy of Vivitrol compare to other OUD treatments?
Vivitrol demonstrates comparable efficacy to buprenorphine and methadone in reducing relapse rates but is less effective for immediate opioid withdrawal symptoms, influencing its role in treatment protocols.

3. What are the main barriers to wider adoption?
High costs, limited provider familiarity outside specialized centers, and insurance reimbursement restrictions hinder broader usage.

4. Will new formulations improve market penetration?
Potentially. Extended-release implants or biodegradable options could improve adherence and reduce injection frequency, expanding patient acceptance and provider interest.

5. How might regulatory changes impact Vivitrol’s market?
Easing of prescribing regulations and expanded approval for broader indications could accelerate adoption and market growth.

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Citations

[1] IQVIA, "Market Insights for Addiction Therapeutics," 2022.
[2] FDA, "Vivitrol (naltrexone) approval history," 2010.
[3] GlobalData, "Opioid Dependence Treatment Market Analysis," 2022.