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Behavioral Naltrexone Therapy for Promoting Adherence to Oral Naltrexone vs Extended Release Injectable Depot Naltrexone (Depot-BNT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00577408
First Posted: December 20, 2007
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
Results First Submitted: July 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Opiate Dependence
Heroin Dependence
Interventions: Drug: depot naltrexone
Drug: Oral Naltrexone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Depot Naltrexone Depot Naltrexone. Vivitrol (380 mg)given monthly depot 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).
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).

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). 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.


Participant Flow:   Overall Study
    Depot Naltrexone   Oral Naltrexone
STARTED   28   32 
COMPLETED   16   9 
NOT COMPLETED   12   23 
Stopped attending study visits                9                11 
Continued opioid use                3                2 
Non-compliance with study meds                0                3 
Refused Oral Naltrexone                0                1 
Moved out of state                0                1 
Scheduling Issues                0                3 
Death                0                1 
Psychiatric hospitalization                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Depot Naltrexone Depot Naltrexone. Vivitrol (380 mg)given monthly depot 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).
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).

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). 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.

Total Total of all reporting groups

Baseline Measures
   Depot Naltrexone   Oral Naltrexone   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   32   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      28 100.0%      32 100.0%      60 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  14.3%      6  18.8%      10  16.7% 
Male      24  85.7%      26  81.3%      50  83.3% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
White   17   21   38 
Hispanic   4   9   13 
Black   5   2   7 
Asian   1   0   1 
Other   1   0   1 
Region of Enrollment 
[Units: Participants]
     
United States   28   32   60 


  Outcome Measures

1.  Primary:   Treatment Retention   [ Time Frame: over the course of 24 weeks or length of study participation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Edward V. Nunes, MD
Organization: New York State Psychiatric Institute
phone: 646-774-6122
e-mail: edward.nunes@nyspi.columbia.edu



Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00577408     History of Changes
Other Study ID Numbers: #5307
R01DA010746 ( U.S. NIH Grant/Contract )
First Submitted: December 18, 2007
First Posted: December 20, 2007
Results First Submitted: July 20, 2017
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017