Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gerardo Gonzalez, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01052662
First received: January 18, 2010
Last updated: September 9, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to examine the effect of memantine and buprenorphine on opioid abusing behavior, to determine the effect of memantine and buprenorphine on early relapse and to evaluate the tolerability of memantine co-administrated with buprenorphine. The study seeks to determine if combined treatment of memantine and buprenorphine may provide shorter-term treatment for opioid dependence.


Condition Intervention Phase
Opioid Dependence
Drug: Memantine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults

Resource links provided by NLM:


Further study details as provided by University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Rates of medication emergent side effects as assessed by weekly questionnaire [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Change in illicit opioid use as measured by self-report drug use and confirmed by urine toxicology [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Early relapse rates as measured by self-report and urine toxicology after agonist discontinuation [ Time Frame: End of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcomes will include weeks in treatment (retention), VAS opioid craving, change in measures of control over impulsive behavior, and anxiety symptoms. [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: October 2009
Estimated Study Completion Date: October 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memantine 30mg/day + Suboxone Drug: Memantine
30mg/day Memantine orally everyday for 12 weeks
Experimental: Memantine 15mg/day + Suboxone Drug: Memantine
15 mg/day Memantine orally everyday for 12 weeks
Placebo Comparator: Memantine 0mg/day + Suboxone Drug: Placebo
Placebo orally everyday for 12 weeks

Detailed Description:

Opiate dependence is an increasing problem among young adults (18-25 years old) whose rates of current use of illicit drugs are generally high (19.7 %)according to data from the 2007 National Survey on Drug Use & Health (Substance Abuse and Mental Health Services Administration 2008). Young adults start using heroin around this age range, and more recently have had increasing rates of prescription-type drug use. Given that young adults with opiate dependence who are seeking treatment are relatively treatment naïve, have a shorter period of addiction, and are more likely to choose buprenorphine over methadone, developing short-term buprenorphine treatment alternatives to long-term methadone agonist treatment is needed.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women between 18-25 years old
  • Opioid dependence as evidenced by signs of opiate withdrawal, self-reported history of opioid dependence for a consecutive 12 month period and positive urine for opioids

Exclusion Criteria:

  • Current diagnosis of other drug or alcohol dependence (other than opiates, cannabis or tobacco)
  • Serious medical illness (e.g. major cardiovascular, renal, endocrine, hepatic disorder)
  • Current serious psychiatric illness or history of psychosis, schizophrenia, bipolar type I disorder and participants with suicidal or homicidal thoughts
  • Women who are pregnant, nursing or refuse to use a reliable form of birth control or refuse monthly pregnancy testing
  • Screening liver function tests (SGOT or SGPT) greater than 3 times normal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052662

Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Gerardo Gonzalez, M.D. University of Massachusetts, Worcester
  More Information

No publications provided

Responsible Party: Gerardo Gonzalez, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01052662     History of Changes
Other Study ID Numbers: H-13261, 1R01DA027138-01
Study First Received: January 18, 2010
Last Updated: September 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Drug Abuse

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Memantine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Antiparkinson Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on July 26, 2014