Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults

Opioid Dependence Clinical Trial

Official title:

Memantine-enhanced Buprenorphine Treatment for Opioid-dependent Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052662
• Other study ID #: H-13261
• Secondary ID: 1R01DA027138-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 18, 2010
• Last updated: March 11, 2015
• Start date: October 2009
• Est. completion date: October 2013

Study information

• Verified date: March 2015
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: October 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Dependence

Intervention

Drug:
• Memantine
30mg/day Memantine orally everyday for 12 weeks
• Memantine
15 mg/day Memantine orally everyday for 12 weeks
• Placebo
Placebo orally everyday for 12 weeks

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Opioid Use From Week 1 to 13	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.	Weekly from week 1 to 13	No
Primary	Number of Participants Who Were Estimated to Have Survived as Assessed by Survival Curve of Relapse Rate After Achieving Complete Abstinence on Week 8	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.	Weeks after buprenorphine discontinuation week 9	No
Secondary	Treatment Retention	Treatment retention during the stabilization period weeks 1 to 8 and after buprenorphine / naloxone discontinuation weeks 9 to 13.	Weekly	No