Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
Merck
Boehringer Ingelheim
Healthtrust
Argus Health
Chinese Patent Office
Harvard Business School
Chubb

Generated: December 9, 2018

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR VIVITROL

« Back to Dashboard

Clinical Trials for Vivitrol

Trial ID Title Status Sponsor Phase Summary
NCT00156923 ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults Completed Alkermes, Inc. Phase 3 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 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 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 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 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 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 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.
Trial ID Title Status Sponsor Phase Summary

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Clinical Trial Conditions for Vivitrol

Condition Name

Condition Name for Vivitrol
Intervention Trials
Alcohol Dependence 11
Opiate Dependence 10
Opioid Dependence 7
Alcoholism 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Condition MeSH

Condition MeSH for Vivitrol
Intervention Trials
Opioid-Related Disorders 17
Alcoholism 16
Disease 6
Alcohol Drinking 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Locations for Vivitrol

Trials by Country

Trials by Country for Vivitrol
Location Trials
United States 85
Norway 5
Russian Federation 2
Netherlands 1
Lithuania 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Trials by US State

Trials by US State for Vivitrol
Location Trials
New York 20
California 9
Maryland 6
Texas 5
Ohio 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Progress for Vivitrol

Clinical Trial Phase

Clinical Trial Phase for Vivitrol
Clinical Trial Phase Trials
Phase 4 14
Phase 3 20
Phase 2/Phase 3 7
[disabled in preview] 17
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Status

Clinical Trial Status for Vivitrol
Clinical Trial Phase Trials
Completed 34
Recruiting 12
Active, not recruiting 6
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Clinical Trial Sponsors for Vivitrol

Sponsor Name

Sponsor Name for Vivitrol
Sponsor Trials
Alkermes, Inc. 24
National Institute on Drug Abuse (NIDA) 20
New York State Psychiatric Institute 10
[disabled in preview] 20
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Sponsor Type

Sponsor Type for Vivitrol
Sponsor Trials
Other 63
Industry 29
NIH 26
[disabled in preview] 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
QuintilesIMS
Fish and Richardson
Deloitte
Citi
Cantor Fitzgerald
US Army
Express Scripts
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.