Memantine as a Supplement to Naltrexone in Treating Heroin Dependence - Full Text View

Purpose

Free treatment for heroin or opiate abuse. Research study involves inpatient detox and outpatient care.

The number of new heroin users and problems associated with heroin use has increased steadily over the past several years. While methadone maintenance remains the most effective treatment for opioid dependence, it has several limitations and is controversial.

Naltrexone maintenance is an alternate treatment for opiate dependence that is promising, but currently has limited usefulness due to poor patient compliance and low patient acceptability. There is strong support from animal research that another class of drugs, NMDA-R antagonists, may also be an effective treatment for opiate dependence. In laboratory animals, NMDA-R antagonists have inhibited behaviors associated with relapse, reduced opiate self-administration, and helped with withdrawal symptoms. In humans, NMDA-R antagonists have reduced signs and symptoms associated with opiate withdrawal and reduced heroin craving. The primary aim of this study is to determine the efficacy of memantine as an adjunct to naltrexone maintenance in detoxified heroin-dependent individuals.

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. In addition to providing treatment referrals, follow up assessments will be completed one, two, and three months after the completion of treatment.

Condition	Intervention	Phase
Opioid Dependence Heroin Dependence	Drug: naltrexone Drug: memantine	Phase II Phase III

MedlinePlus related topics:

Heroin

ChemIDplus related topics:

Memantine Memantine hydrochloride Naltrexone Naltrexone hydrochloride Diacetylmorphine Diacetylmorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Memantine and Naltrexone Treatment for Opioid Dependence

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

urine toxicology results [ Time Frame: 3x/week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

self reported opiate use [ Time Frame: daily ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	June 2005
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)	Drug: naltrexone intramuscular injection of Vivitrol 380 mg Drug: memantine Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose).
2: Placebo Comparator intramuscular injection of Vivitrol 380 mg and Placebo	Drug: naltrexone intramuscular injection of Vivitrol 380 mg

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult, aged 18-60.
Meets DSM-IV criteria for current opiate dependence disorder of at least six months duration, supported by a positive urine for opiates and a positive naloxone challenge test if the diagnosis is unclear.
Able to give informed consent.

Exclusion Criteria:

Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
Active medical illness which might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels >2 times normal, unstable diabetes, chronic organic mental disorder (e.g., AIDS dementia).
Active psychiatric disorder which might interfere with participation or make participation hazardous, including DSM-IV schizophrenia, bipolar disorder with mania or psychosis, and depressive disorder with suicide risk or 1 or more suicide attempts within the past year.
History of allergic reaction to buprenorphine, naloxone, memantine, naltrexone, clonidine, or clonazepam.
Currently prescribed or regularly taking opiates for chronic pain or medical illness.
Current participation in another intensive psychotherapy or substance abuse treatment program or currently prescribed psychotropic medications.
Current participation in a methadone maintenance treatment program and/or regular use of illicit methadone (>30 mg per week).
History of accidental drug overdose in the last three years or any other significant history of overdose following detoxification defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476242

Contacts


Contact: John Lazar, BA	212- 923-3031	jolazar@pi.cpmc.columbia.edu

Contact: Julianne Kurtz, BA	212-923-3031	kurtzju@pi.cpmc.columbia.edu

Locations


United States, New York
	STARS	Recruiting
	New York, New York, United States, 10032
	Contact: John Lazar, BA 212-923-3031 jolazar@pi.cpmc.columbia.edu
	Contact: Julianne Kurtz, BA 212-923-3031 kurtzju@pi.cpmc.columbia.edu
	Principal Investigator: Adam Bisaga, MD

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators


Principal Investigator:	Adam Bisaga, MD	Columbia University

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	NYSPI ( Adam Bisaga, MD )
Study ID Numbers:	R01-15822-1, R01-15822-1
First Received:	May 17, 2007
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00476242
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):

heroin abuse

opiate abuse

opioid dependence

naltrexone

memantine

Study placed in the following topic categories:

Excitatory Amino Acids

Dopamine

Heroin

Mental Disorders

Heroin Dependence

Naltrexone

Substance-Related Disorders

Memantine

Disorders of Environmental Origin

Opioid-Related Disorders

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Anti-Dyskinesia Agents

Narcotic Antagonists

Physiological Effects of Drugs

Antiparkinson Agents

Excitatory Amino Acid Agents

Pharmacologic Actions

Sensory System Agents

Therapeutic Uses

Dopamine Agents

Peripheral Nervous System Agents

Central Nervous System Agents

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00476242