Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gerardo Gonzalez, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT01052662
First received: January 18, 2010
Last updated: March 11, 2015
Last verified: March 2015
  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 2
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:
  • Change of Opioid Use From Week 1 to 13 [ Time Frame: Weekly from week 1 to 13 ] [ Designated as safety issue: No ]
    The primary outcome variable was the change from baseline of the mean proportion of weekly opioid use assessed by self-reported days of use and/or positive urine drug screen during the previous week using the time-line followed-back method (TLFB) . A positive urine counted as 1, as did each self-reported day of use. Each participants total was divided by 8. Mean proportion by group were calculated by averaging the proportions across participants in that group.

  • Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8 [ Time Frame: Weeks after buprenorphine discontinuation week 9 ] [ Designated as safety issue: No ]
    Calculated survival curve from abstinence in Week 8 to first positive opioid urine screen or first reported relapse to opioid use to evaluate the effect of memantine on reducing early relapse and after rapid buprenorphine discontinuation on week 9. The last observation carried forward (LOCF) was used to perform our event survival analyses.


Secondary Outcome Measures:
  • Treatment Retention [ Time Frame: Weekly ] [ Designated as safety issue: No ]
    Treatment retention during the stabilization period weeks 1 to 8 and after buprenorphine / naloxone discontinuation weeks 9 to 13.


Enrollment: 87
Study Start Date: October 2009
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 + Buprenorphine

Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.

Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.

Drug: Memantine
30mg/day Memantine orally everyday for 12 weeks
Experimental: Memantine 15mg/day + Buprenorphine

Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.

Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.

Drug: Memantine
15 mg/day Memantine orally everyday for 12 weeks
Placebo Comparator: Memantine 0mg/day + Buprenorphine

Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.

Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.

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
Results First Received: January 14, 2015
Last Updated: March 11, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Massachusetts, Worcester:
Drug Abuse

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

ClinicalTrials.gov processed this record on March 31, 2015