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

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. Identifier: NCT01690546
Recruitment Status : Completed
First Posted : September 21, 2012
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Alkermes, Inc.
Information provided by (Responsible Party):
Paolo Mannelli, Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Opiate Dependence
Interventions: Drug: very low dose naltrexone
Drug: extended release naltrexone
Drug: buprenorphine/naloxone

  Participant Flow

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
BUP/VLNXT to VIVITROL No text entered.

Participant Flow:   Overall Study
Extended Release Injectable NTX   27 

  Baseline Characteristics

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
BUP/VLNXT to VIVITROL No text entered.

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Years]
Mean (Full Range)
 (25 to 65) 
[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)
 (7 to 18) 

  Outcome Measures

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

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
No text entered.

  More Information

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

Responsible Party: Paolo Mannelli, Duke University Identifier: NCT01690546     History of Changes
Other Study ID Numbers: Pro00036909
First Submitted: September 19, 2012
First Posted: September 21, 2012
Results First Submitted: February 22, 2016
Results First Posted: June 1, 2016
Last Update Posted: June 1, 2016