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Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence (BUP/NXT-VIVI)

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Paolo Mannelli, Duke University Medical Center
ClinicalTrials.gov Identifier:
NCT01690546
First received: September 19, 2012
Last updated: April 25, 2016
Last verified: April 2016
Results First Received: February 22, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Opiate Dependence
Interventions: Drug: very low dose naltrexone
Drug: extended release naltrexone
Drug: buprenorphine/naloxone

  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
38 participants signed consent. 3 participants were screen failures. 35 participants started study.

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
BUP/VLNXT to VIVITROL No text entered.

Participant Flow:   Overall Study
    BUP/VLNXT to VIVITROL  
STARTED     35  
Extended Release Injectable NTX     27  
COMPLETED     26  
NOT COMPLETED     9  



  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
BUP/VLNXT to VIVITROL No text entered.

Baseline Measures
    BUP/VLNXT to VIVITROL  
Number of Participants  
[units: participants]
  35  
Age  
[units: years]
Mean (Full Range)
  40.1  
  (25 to 65)  
Gender  
[units: participants]
 
Female     9  
Male     26  
Race/Ethnicity, Customized  
[units: participants]
 
African American     26  
Caucasian     9  
Years of Opioid use  
[units: years]
Mean (Full Range)
  9.7  
  (7 to 18)  



  Outcome Measures
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1.  Primary:   Retention in Treatment   [ Time Frame: 4 weeks ]

2.  Secondary:   Withdrawal Intensity as Measured by the Clinical Opiate Withdrawal Scale (COWS)   [ Time Frame: 4 weeks ]

3.  Secondary:   Withdrawal Intensity as Measured by the Subjective Opiate Withdrawal Scale (SOWS)   [ Time Frame: 4 weeks ]

4.  Secondary:   Craving   [ Time Frame: 4 weeks ]

5.  Secondary:   Illicit Drug Use, Measured by Urine Drug Testing   [ Time Frame: 4 weeks ]

6.  Secondary:   Satisfaction With Treatment, Measured by a Treatment Satisfaction Questionnaire   [ Time Frame: Day 9 ]

7.  Secondary:   Percentage of Participants Who Adhered to Study Visits.   [ Time Frame: baseline to end of study (approximately 40 days) ]

8.  Secondary:   Percentage of Participants With Adherence to Medication (Naltrexone)   [ Time Frame: Day 1 to Day 8 (+/- 2 days) ]

9.  Secondary:   Use of Ancillary Medications.   [ Time Frame: baseline to week 1 ]

10.  Secondary:   Number of Participants That Self Reported Illicit Drug Use   [ Time Frame: 4 weeks ]


  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: Paolo Mannelli, M.D
Organization: Duke University Medical Center
phone: 919-681-0613
e-mail: paolo.mannelli@dm.duke.edu



Responsible Party: Paolo Mannelli, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT01690546     History of Changes
Other Study ID Numbers: Pro00036909
Study First Received: September 19, 2012
Results First Received: February 22, 2016
Last Updated: April 25, 2016
Health Authority: United States: Food and Drug Administration