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Pilot Study of Depot NTX in Homeless Veterans

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ClinicalTrials.gov Identifier: NCT01155869
Recruitment Status : Terminated (Poor enrollment)
First Posted : July 2, 2010
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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
Enrollment 7
Recruitment Details 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 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.
Arm/Group Title XR-NTX Oral Naltrexone
Hide Arm/Group Description Depot naltrexone (Vivitrol) 380 mg. IM monthly Naltrexone 50 mg tablet PO daily
Period Title: Overall Study
Started 3 4
Completed 0 3
Not Completed 3 1
Reason Not Completed
Lost to Follow-up             3             1
Arm/Group Title XR-NTX Oral Naltrexone Total
Hide Arm/Group Description Depot naltrexone (Vivitrol) 380 mg. IM monthly Naltrexone 50 mg tablet PO daily Total of all reporting groups
Overall Number of Baseline Participants 3 4 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
4
 100.0%
7
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
4
 100.0%
7
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 4 participants 7 participants
3 4 7
1.Primary Outcome
Title Mean Weekly Self-reported Alcohol Consumption
Hide Description Mean number of standard drinks per week during the 24 week study. A standard drink is any drink that contains about 14 grams of pure alcohol, e.g. 12 ounces of beer, 5 ounces of wine or 1.5 ounces of spirits.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title XR-NTX Oral Naltrexone
Hide Arm/Group Description:
Depot naltrexone (Vivitrol) 380 mg. IM monthly
Naltrexone 50 mg tablet PO daily
Overall Number of Participants Analyzed 3 4
Mean (Standard Deviation)
Unit of Measure: standard drink
0  (0) 65  (10.6)
2.Secondary Outcome
Title Treatment Participation
Hide Description Percentage of total during-treatment study visits attended. This serves as a proxy for the number of months of treatment participation
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title XR-NTX Oral Naltrexone
Hide Arm/Group Description:
Depot naltrexone (Vivitrol) 380 mg. IM monthly
Naltrexone 50 mg tablet PO daily
Overall Number of Participants Analyzed 3 4
Overall Number of Units Analyzed
Type of Units Analyzed: Visits
12 16
Measure Type: Number
Unit of Measure: percentage of visits
33.3 87.5
Time Frame 24 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title XR-NTX Oral Naltrexone
Hide Arm/Group Description Depot naltrexone (Vivitrol) 380 mg. IM monthly Naltrexone 50 mg tablet PO daily
All-Cause Mortality
XR-NTX Oral Naltrexone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
XR-NTX Oral Naltrexone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/4 (0.00%)    
Investigations     
death  [1]  1/3 (33.33%)  1 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Pt missed appt for second injection and study interview. In trying to locate the subject, RA periodically checked CPRS. Record located in CPRS noted death.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
XR-NTX Oral Naltrexone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/4 (25.00%)    
Gastrointestinal disorders     
Nausea/Vomiting  [1]  0/3 (0.00%)  0 1/4 (25.00%)  1
Social circumstances     
Arrest   0/3 (0.00%)  0 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
[1]
Emergency department visit
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Peter Friedmann
Organization: Providence VA Medical Center
Phone: 401-273-7100 ext 6240
EMail: peter.friedmann@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT01155869    
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