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Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00781898
First Posted: October 29, 2008
Last Update Posted: October 23, 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):
University of Pennsylvania
Results First Submitted: April 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Opiate Addiction
Interventions: Drug: Depot naltrexone
Other: Treatment as Usual (TAU)

  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
Community-dwelling adult volunteers who had been incarcerated and who had a history of opioid dependence.

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® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
Placebo Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant

Participant Flow:   Overall Study
    Depot Naltrexone   Placebo
STARTED   153   155 
COMPLETED   119   126 
NOT COMPLETED   34   29 



  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.
Participants in this arm were randomized to Depot Nalttrexone (Extended Release Naltrexone)

Reporting Groups
  Description
Depot Naltrexone Participants who were randomized to receive Extended Release Naltrexone
Placebo Treatment as Usual (TAU): Treatment as Usual (TAU) community treatment provided to the participant
Total Total of all reporting groups

Baseline Measures
   Depot Naltrexone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 153   155   308 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      153 100.0%      155 100.0%      308 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 44  (9.2)   43  (9.4)   43.5  (9.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  15.7%      23  14.8%      47  15.3% 
Male      129  84.3%      132  85.2%      261  84.7% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   153   155   308 


  Outcome Measures

1.  Primary:   Relapse   [ Time Frame: 6 months ]


  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: Charle P. O'Brien
Organization: University Of Pennsylvania
phone: 215-222-3200
e-mail: obrien@mail.med.upenn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00781898     History of Changes
Other Study ID Numbers: 808422
R01DA024553 ( U.S. NIH Grant/Contract )
First Submitted: October 24, 2008
First Posted: October 29, 2008
Results First Submitted: April 17, 2017
Results First Posted: October 23, 2017
Last Update Posted: October 23, 2017