A Phase 3 interventional study of depot naltrexone and Oral Naltrexone in Opiate 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 2017-08-25.
Sponsored by New York State Psychiatric Institute · Phase 3, Interventional, and Treatment
In pilot study now proposed, we plan to randomly assign 60 opioid dependent patients to the new model, Depot-BNT, or to BNT plus oral naltrexone for a 6-month trial. This will provide initial clinical experience with the new Depot-BNT treatment model, while providing a rigorous test of whether Depot-BNT produces superior treatment outcome, compared to our best behavioral platform for oral naltrexone (BNT).
The following aims will be addressed:
Specific Aim #1: To test whether Depot-BNT increases retention in treatment and improves drug use outcome (urine-confirmed abstinent weeks) compared to our established model of BNT with oral naltrexone (BNT-Oral), and to explore whether Depot-BNT (vs BNT-Oral) improves key secondary outcomes including dysphoria, HIV risk behavior, and social functioning.
Specific Aim #2: To explore predictors of outcome on Depot-BNT, and mechanisms of attrition, in order to optimize Depot-BNT prior to further testing.
The clinical trial now proposed will provide an initial test of the feasibility and efficacy of the newly adapted version of Behavioral Naltrexone Therapy for Depot Naltrexone (Depot-BNT). Treatment-seeking opiate-dependent patients will be admitted for inpatient detoxification and induction onto oral naltrexone. Those who are successfully inducted will be randomly assigned for a six month trial to one of two conditions: 1) Behavioral Naltrexone Therapy for Depot Naltrexone (Depot-BNT) (N = 30), with the first dose of depot naltrexone administered prior to discharge from hospital with monthly doses thereafter; or 2) Behavioral Naltrexone Therapy as previously developed for promoting compliance with daily oral naltrexone (BNT-Oral) (N = 30). All patients in both groups will be asked to attend twice weekly outpatient therapy sessions over a six month course. This design will provide a test of whether Depot-BNT produces superior treatment retention and drug use outcome in comparison to our established behavioral platform for oral naltrexone, while providing experience upon which to base revisions of Depot-BNT prior to embarking upon further Stage 2 testing. Treatment will take place at the same sites as for our prior studies: (1) the General Clinical Research Unit (GCRU) of New York State Psychiatric Institute (NYSPI) and (2) the Substance Treatment and Research Service (STARS) of the Division on Substance Abuse at NYSPI.
90 studies on the registry are indexed under Heroin Dependence; 1 is open to participants now.
This study's enrollment of 60 is below 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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Depot Naltrexone. Vivitrol (380 mg)given monthly
Drug: depot naltrexone
Oral Naltrexone. For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday).
Drug: Oral Naltrexone
On the afternoon of Day 7, patients assigned to Depot-BNT receive an intramuscular injection of Vivitrol (380 mg) in one buttock. The patient spends the night of Day 7 in the hospital and is discharged on the morning of Day 8. Each injection contains 192 mg of naltrexone. The double dose (384 mg) is what was found to produce optimal blockade and outcome in preliminary work. During the subsequent 6-month course of outpatient treatment, patients are dosed with two injections (384 mg total) of depot naltrexone at monthly intervals (weeks 4, 8, 12, 16, 20).
Also known as: Vivitrol
For patients assigned to BNT-Oral, administration is clinic-based for at least the first two weeks, and doses are 50mg, 100mg, or 150mg, depending on whether one, two or three days will elapse before the next visit (typically 100 mg on Monday and Wednesday and 150 mg on Friday). The ultimate goal with BNT-Oral is for patients to take naltrexone (50 mg per day) on their own at home under supervision of their significant other/monitor.
Also known as: Revia
Treatment Retention
compliance with being retained in treatment protocol
Time frame: over the course of 24 weeks or length of study participation
| Milestone | Depot Naltrexone | Oral Naltrexone |
|---|---|---|
| Started | 28 | 32 |
| Completed | 16 | 9 |
| Not completed | 12 | 23 |
| Withdrew: Stopped attending study visits | 9 | 11 |
| Withdrew: Continued opioid use | 3 | 2 |
| Withdrew: Non-compliance with study meds | 0 | 3 |
| Withdrew: Refused oral naltrexone | 0 | 1 |
| Withdrew: Moved out of state | 0 | 1 |
| Withdrew: Scheduling issues | 0 | 3 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Psychiatric hospitalization | 0 | 1 |
compliance with being retained in treatment protocol
| Participants | Depot Naltrexone | Oral Naltrexone |
|---|---|---|
| 4 Weeks | 24 | 20 |
| 12 Weeks | 17 | 14 |
| 24 Weeks | 16 | 9 |
Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Depot Naltrexone | — | 6/28 (21.4%) | 16/28 (57.1%) |
| Oral Naltrexone | — | 3/32 (9.4%) | 25/32 (78.1%) |
| Event | Depot Naltrexone | Oral Naltrexone |
|---|---|---|
| car accidentMusculoskeletal and connective tissue disorders | 2/28 | 0/32 |
| hypertensionVascular disorders | 1/28 | 0/32 |
| Spontaneous abortionReproductive system and breast disorders | 1/28 | 0/32 |
| Allergic reactionSkin and subcutaneous tissue disorders | 1/28 | 0/32 |
| increased anxietyPsychiatric disorders | 1/28 | 0/32 |
| chest painVascular disorders | 0/28 | 1/32 |
| Cannabis induced psychosisPsychiatric disorders | 0/28 | 1/32 |
| Cardiac deathVascular disorders | 0/28 | 1/32 |
| Event | Depot Naltrexone | Oral Naltrexone |
|---|---|---|
| InsomniaPsychiatric disorders | 7/28 | 14/32 |
| DiarrheaGastrointestinal disorders | 0/28 | 6/32 |
| AnxietyPsychiatric disorders | 5/28 | 5/32 |
| depressionPsychiatric disorders | 4/28 | 0/32 |
| Age, Categorical(Participants) | Depot Naltrexone | Oral Naltrexone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 28 | 32 | 60 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Depot Naltrexone | Oral Naltrexone | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 24 | 26 | 50 |
| Race/Ethnicity, Customized(Participants) | Depot Naltrexone | Oral Naltrexone | Total |
|---|---|---|---|
| White | 17 | 21 | 38 |
| Hispanic | 4 | 9 | 13 |
| Black | 5 | 2 | 7 |
| Asian | 1 | 0 | 1 |
| Other | 1 | 0 | 1 |
| Region of Enrollment(participants) | Depot Naltrexone | Oral Naltrexone | Total |
|---|---|---|---|
| United States | 28 | 32 | 60 |
Plan to share: No
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Studies of the drug tested here: Naltrexone
New York State Psychiatric Institute →