CompletedNCT00577408Depot-BNTUpdated Aug 25, 2017Results posted

Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone

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

Phase: Phase 3
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

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.

Read the detailed description

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.

Conditions studied

Opiate Dependence
Heroin Dependence

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Keywords

Opiate Dependence
Heroin Dependence
Naltrexone

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age 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. If participating as an outpatient only, recent opiate dependence must be confirmed by clinical history and/or communication with former treatment provider.
Seeking treatment for heroin dependence.
Able to give informed consent.

Exclusion criteria

Exclusion Criteria:

Methadone maintenance treatment or regular use of illicit methadone (> 30 mg per week).
Maintenance on, or regular use of buprenorphine or other long-acting narcotic agonists.
Pregnancy, lactation, or failure in a sexually active woman to use adequate contraceptive methods.
Active medical illness which might make participation hazardous, such as untreated hypertension, hepatitis with SGOT or SGPT > 3 times normal, unstable diabetes.
Active psychiatric disorder which 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.
Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal. Other substance use diagnoses are not exclusionary. Multiple substance use is common in this population, and such an exclusion would rule out a large proportion of the population and limit the generalizability of the study.
History of allergic reaction to buprenorphine, naltrexone, naloxone, clonidine, or clonazepam.
Chronic organic mental disorder (e.g. AIDS dementia).
History of accidental drug overdose in the last 3 years as defined as an episode of opioid-induced unconsciousness or incapacitation, whether or not medical treatment was sought or received.
Currently receiving any other investigational drug, or has used any other investigational drug within 30 days of study entry.
Currently prescribed or regularly taking opiates for chronic pain or medical illness or those individuals anticipating surgical procedures which will necessitate opioid medications.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 60 participants (actual)

Study arms

Experimental
Depot Naltrexone
Depot Naltrexone. Vivitrol (380 mg)given monthly
Drug: depot naltrexone
Active comparator
Oral 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

Interventions

Drugdepot 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
DrugOral 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). 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

What researchers measure

Primary outcomes

Treatment Retention
compliance with being retained in treatment protocol
Time frame: over the course of 24 weeks or length of study participation

Results

Posted Aug 25, 2017

Participant flow

Participant flow — Overall Study
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

Outcome measures

PrimaryTreatment Retention

compliance with being retained in treatment protocol

Time frame:: over the course of 24 weeks or length of study participation
Reported as:: Count of participants · Participants

Treatment Retention
Participants	Depot Naltrexone	Oral Naltrexone
4 Weeks	24	20
12 Weeks	17	14
24 Weeks	16	9

Adverse events

Collected over 24 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Depot Naltrexone	—	6/28 (21.4%)	16/28 (57.1%)
Oral Naltrexone	—	3/32 (9.4%)	25/32 (78.1%)

Most frequent serious events

Most frequent serious events
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

Most frequent other events

Most frequent other events
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

Baseline characteristics

Age, Categorical
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
Sex: Female, Male(Participants)	Depot Naltrexone	Oral Naltrexone	Total
Female	4	6	10
Male	24	26	50

Race/Ethnicity, Customized
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
Region of Enrollment(participants)	Depot Naltrexone	Oral Naltrexone	Total
United States	28	32	60

Study locations

1 site

New York State Psychiatric Institute
New York, New York 10032, United States

References and documents

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT00577408
Lead sponsor: New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse (NIDA)
Responsible party: Sponsor
First posted: Dec 20, 2007
Start date: Sep 2007
Primary completion: Aug 2011
Completion: Aug 2011
Results posted: Aug 25, 2017
Last update: Aug 25, 2017

Study contacts

Edward Nunes, M.D.

study director · Columbia University

Maria Sullivan, M.D.

principal investigator · Columbia University

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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