Pilot Study of Depot NTX in Homeless Veterans

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: NCT01155869
Recruitment Status : Terminated (Poor enrollment)
First Posted : July 2, 2010
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Alcohol Dependence
Interventions: Drug: Depot naltrexone
Drug: Oral Naltrexone

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
215 potential subjects were approached over a 16-month period of recruitment; only 15 agreed to be screen after hearing of study procedures.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5 were excluded (1 did not meet criteria for homelessness, 1 did not meet criteria for alcohol dependence, 1 had untreated delusional thinking, and 2 had opioid-requiring pain); 3 eligible participants did not appear for baseline interview and could not be found; only 7 were randomized.

Reporting Groups
XR-NTX Depot naltrexone (Vivitrol) 380 mg. IM monthly
Oral Naltrexone Naltrexone 50 mg tablet PO daily

Participant Flow:   Overall Study
    XR-NTX   Oral Naltrexone
STARTED   3   4 
COMPLETED   0   3 
Lost to Follow-up                3                1 

  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
XR-NTX Depot naltrexone (Vivitrol) 380 mg. IM monthly
Oral Naltrexone Naltrexone 50 mg tablet PO daily
Total Total of all reporting groups

Baseline Measures
   XR-NTX   Oral Naltrexone   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   4   7 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   3   4   7 
>=65 years   0   0   0 
[Units: Participants]
Female   0   0   0 
Male   3   4   7 
Region of Enrollment 
[Units: Participants]
United States   3   4   7 

  Outcome Measures

1.  Primary:   Mean Weekly Self-reported Alcohol Consumption   [ Time Frame: 24 weeks ]

2.  Secondary:   Treatment Participation   [ Time Frame: 16 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
Only 15 of 215 alcohol-dependent, homeless veterans would consider a study that included an intramuscular injection of XR-NTX. Of 3 given XR-NTX, only 1 returned for injection #2. Aversion to injection likely contributed to poor acceptability.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Peter Friedmann
Organization: Providence VA Medical Center
phone: 401-273-7100 ext 6240

Publications of Results:

Responsible Party: VA Office of Research and Development Identifier: NCT01155869     History of Changes
Other Study ID Numbers: PPO 10-079
First Submitted: June 30, 2010
First Posted: July 2, 2010
Results First Submitted: September 17, 2013
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014