A Phase 2/3 interventional study of Vivitrol and memantine in Opioid Dependence and Heroin Dependence, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-07-17.
Sponsored by New York State Psychiatric Institute · Phase 2/3, Interventional, and Treatment
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 the proposed trial heroin-dependent patients undergoing detoxification 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 goal of psychosocial intervention is to improve compliance with medication and maintain abstinence. A double-blind trial will last twelve weeks with assessments at baseline and at each appointment three times per week. After the completion of a double-blind study (experimental phase), participants will continue open label treatment with Vivitrol and therapy for additional three months (study extension phase). Repeated assessments will also be completed one, two, and three months following the end of double-blind treatment. For the experimental phase of the study, the primary aim is to test the efficacy of memantine in reducing early attrition and improving outcome in opioid-dependent individuals maintained on naltrexone and primary outcome measures will be retention in treatment by the end of the study and heroin abstinence.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 82 is close to the median of 87 across 57 interventional studies indexed under Heroin Dependence.
Browse Heroin Dependence studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Compared within Heroin Dependence, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Opioid-Related Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)
Drug: Vivitrol · Drug: memantine
intramuscular injection of Vivitrol 380 mg and Placebo
Drug: Vivitrol
intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)
Also known as: intramuscular injection of Vivitrol 380 mg
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), for a total of twelve weeks of medication treatment.
Opiate Use Measured by Urine Toxicology Results
Opiate use was qualified by the number of opiate positive urine results.
Time frame: 3x/week during 12 weeks of the trial or study participation
Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no).
Time frame: Week 12
Opiate Craving Based on Heroin Craving Scale
Range 0- 100 ( 0= no craving; 100= very strong craving
Time frame: Average of twice weekly assessments for 12 weeks of study or length of participation
| Milestone | Placebo and Vivitrol | Memantine and Vivitrol |
|---|---|---|
| Started | 27 | 28 |
| Completed | 19 | 12 |
| Not completed | 8 | 16 |
Opiate use was qualified by the number of opiate positive urine results.
| Percent of total urine samples | Memantine and Vivitrol | Placebo and Vivitrol |
|---|---|---|
| Opiate Use Measured by Urine Toxicology Results | 9 (3 to 40) | 10 (0 to 19) |
| participants | Memantine and Vivitrol | Placebo and Vivitrol |
|---|---|---|
| Retention in Treatment The Primary Outcome Measure Will be the Dichotomous Measure Retention in Treatment (Whether the Patient Completes the 12 Week Trial, Yes/no). | 12 | 19 |
Range 0- 100 ( 0= no craving; 100= very strong craving
| units on a scale | Placebo and Vivitrol | Memantine and Vivitrol |
|---|---|---|
| Opiate Craving Based on Heroin Craving Scale | 18.47 ± 25.79 | 15.74 ± 22.22 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Memantine and Vivitrol | — | 1/28 (3.6%) | 20/28 (71.4%) |
| Placebo and Vivitrol | — | 0/27 (0%) | 17/27 (63%) |
| Event | Memantine and Vivitrol | Placebo and Vivitrol |
|---|---|---|
| Psychiatric worseningPsychiatric disorders | 1/28 | 0/27 |
| Event | Memantine and Vivitrol | Placebo and Vivitrol |
|---|---|---|
| InsomniaPsychiatric disorders | 17/28 | 13/27 |
| Mood changesPsychiatric disorders | 7/28 | 9/27 |
| Fatigue/drowsinessPsychiatric disorders | 7/28 | 8/27 |
| GI DistressPsychiatric disorders | 4/28 | 7/27 |
| DiarrheaPsychiatric disorders | 7/28 | 3/27 |
| Body AchesPsychiatric disorders | 4/28 | 6/27 |
| Increased/decreased appetitePsychiatric disorders | 6/28 | 5/27 |
| Sweating/chillsPsychiatric disorders | 2/28 | 5/27 |
| Nausea/VomitingPsychiatric disorders | 1/28 | 4/27 |
| HeadachePsychiatric disorders | 2/28 | 4/27 |
| Age, Continuous(years) | Memantine and Vivitrol | Placebo and Vivitrol | Total |
|---|---|---|---|
| Mean | 39.7 ± 12.0 | 39.0 ± 11.5 | 39.4 ± 11.5 |
| Sex: Female, Male(Participants) | Memantine and Vivitrol | Placebo and Vivitrol | Total |
|---|---|---|---|
| Female | 4 | 7 | 11 |
| Male | 24 | 20 | 44 |
| Region of Enrollment(participants) | Memantine and Vivitrol | Placebo and Vivitrol | Total |
|---|---|---|---|
| United States | 28 | 27 | 55 |
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Memantine
New York State Psychiatric Institute →