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CLINICAL TRIALS PROFILE FOR NALMEFENE HYDROCHLORIDE

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Clinical Trials for Nalmefene Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT00000437	Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 4	The purpose of this study is to determine the effectiveness of naltrexone (Revia) in reducing drinking and smoking in patients with both nicotine and alcohol dependence. Individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.
NCT00000437	Tobacco Dependence in Alcoholism Treatment (Nicotine Patch/Naltrexone)	Completed	The Scripps Research Institute	Phase 4	The purpose of this study is to determine the effectiveness of naltrexone (Revia) in reducing drinking and smoking in patients with both nicotine and alcohol dependence. Individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (Revia) and nicotine replacement patch or placebos. All individuals will receive weekly coping skills and smoking-cessation behavioral therapy. Followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.
NCT00000450	Naltrexone Maintenance Treatment of Alcoholism	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 4	The purpose of this study is to determine the long-term effectiveness of naltrexone treatment in alcohol-dependent patients who respond to short-term treatment. Those who respond to short-term treatment will be randomized to a 1-year, double-blind, placebo-controlled maintenance phase with a 6-month posttreatment followup.

Clinical Trial Conditions for Nalmefene Hydrochloride

Condition Name

Condition Name for Nalmefene Hydrochloride
Intervention	Trials
Alcohol Dependence	10
Alcoholism	3
Alcohol Use Disorder	2

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Condition MeSH

Condition MeSH for Nalmefene Hydrochloride
Intervention	Trials
Alcoholism	13
Alcohol Drinking	4
Disease	3

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Clinical Trial Locations for Nalmefene Hydrochloride

Trials by Country

Trials by Country for Nalmefene Hydrochloride
Location	Trials
United States	6
Germany	4
France	4
Japan	3
Poland	2

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Trials by US State

Trials by US State for Nalmefene Hydrochloride
Location	Trials
Connecticut	2
Florida	2
Maryland	1
Minnesota	1

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Clinical Trial Progress for Nalmefene Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Nalmefene Hydrochloride
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	6
Phase 2/Phase 3	1

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Clinical Trial Status

Clinical Trial Status for Nalmefene Hydrochloride
Clinical Trial Phase	Trials
Completed	11
Recruiting	7
Not yet recruiting	3

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Clinical Trial Sponsors for Nalmefene Hydrochloride

Sponsor Name

Sponsor Name for Nalmefene Hydrochloride
Sponsor	Trials
H. Lundbeck A/S	9
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	4
Otsuka Pharmaceutical Co., Ltd.	3

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Sponsor Type

Sponsor Type for Nalmefene Hydrochloride
Sponsor	Trials
Other	16
Industry	14
NIH	5

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