Opioid DependencePhase 2NAMHS-1NCT00125515
Memantine and Naltrexone Treatment for Opioid Dependence
A Phase 2 study testing Memantine and Naltrexone in people with Opioid Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Memantine and Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Aug 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or breastfeeding
- Failure in a sexually active woman to use adequate contraceptive methods
- Active medical illness that might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels > 2 times normal, unstable diabetes, or chronic organic mental disorder (e.g., AIDS dementia)
- Active psychiatric disorder that 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
Show all 9Show fewer
- 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 3 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Evaluation of NMDA Antagonist for Opiate Dependence
The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.
Read the detailed description
The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone.
This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. In addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. Baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.
- Conditions
- Opioid Dependence
- Being tested
- Memantine, Naltrexone
- Keywords
- Heroin, Opiates, naltrexone, memantine
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
One arm receives 30 mg bid and the other arm receives receives 15mg bid
NaltrexoneDrug
Patients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo plus oral naltrexone Receives: Drug: Naltrexone |
| Memantine 30 mg bid | Active comparator | Memantine 30 mg bid plus oral naltrexone Receives: Drug: Memantine; Drug: Naltrexone |
| Memantine 15 mg bid | Active comparator | memantine 15 mg bid plus oral naltrexone Receives: Drug: Memantine; Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention in Treatment
The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.
Measured: Number of participants who complete 12 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2005 (estimated)
- Study startJun 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Adam Bisaga, New York State Psychiatric Institute
- Investigators
- Adam Bisaga, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125515
- Sponsor's protocol ID
- #4847/R01-15822
- Other IDs
- K23DA000429
- Acronym
- NAMHS-1
- Status last verified
- May 2018
- First submitted
- 28 Jul 2005
- Last updated
- 18 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NMDA Antagonist for Opiate Dependence
- ClinicalTrials.gov ID
- NCT00125515
- Acronym / sponsor ID
- NAMHS-1 / #4847/R01-15822
- Conditions
- Opioid Dependence
- Keywords
- Heroin, Opiates, naltrexone, memantine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 1 Aug 2005 (estimated)
- Results
- Posted 24 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test the efficacy of memantine (a noncompetitive NMDA receptor antagonist) as an adjunct to the maintenance treatment with naltrexone in detoxified heroin-dependent individuals.
Detailed description
The primary aim of this study is to test the efficacy of memantine, a noncompetitive NMDA receptor antagonist, in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone.
This double-blind, 12-week trial will include heroin-dependent patients who completed detoxification. Participants will be randomly assigned to one of three conditions: naltrexone and placebo, naltrexone and memantine (15 mg bid), or naltrexone and memantine (30 mg bid). Naltrexone will be taken 3 times each week at the clinic, while memantine or placebo will be taken at home. In addition, twice each week patients will receive a psychosocial intervention that will include motivational interviewing and cognitive-behavioral relapse prevention. The goal of the psychosocial intervention is to improve compliance with medication and maintain abstinence. Baseline assessments will be taken and compared to those completed at study visits, which will occur 3 times each week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: NaltrexonePlacebo plus oral naltrexone |
| Memantine 30 mg bid | Active comparator | Drug: Memantine, Drug: NaltrexoneMemantine 30 mg bid plus oral naltrexone |
| Memantine 15 mg bid | Active comparator | Drug: Memantine, Drug: Naltrexonememantine 15 mg bid plus oral naltrexone |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- Pregnancy or breastfeeding
- Failure in a sexually active woman to use adequate contraceptive methods
- Active medical illness that might make participation hazardous, such as untreated hypertension, acute hepatitis with SGOT or SGPT levels > 2 times normal, unstable diabetes, or chronic organic mental disorder (e.g., AIDS dementia)
- Active psychiatric disorder that 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineOne arm receives 30 mg bid and the other arm receives receives 15mg bid | Drug | Memantine 15 mg bid, Memantine 30 mg bid |
| NaltrexonePatients received the equivalent of 50 mg/day. Dispensed as 100 mg on Mondays and Wednesdays and 150 mg on Fridays. | Drug | Memantine 15 mg bid, Memantine 30 mg bid, Placebo |
Primary outcome
Retention in Treatment
Time frame: Number of participants who complete 12 weeks of treatment
The number of participants who were retained and completed all 12 weeks of treatment and study participation were compared between the three study groups.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- stars websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Bisaga, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine and Naltrexone in people with Opioid Dependence, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in Treatment (time frame: Number of participants who complete 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.