Pilot Study of Depot NTX in Homeless Veterans

• ClinicalTrials.gov Identifier: NCT01155869
• Recruitment Status: Terminated
• First Posted: July 2, 2010
• Results First Posted: July 17, 2014
• Last Update Posted: July 17, 2014
• Sponsor: US Department of Veterans Affairs
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		XR-NTX	Oral Naltrexone	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Mean Weekly Self-reported Alcohol Consumption
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XR-NTX	Oral Naltrexone
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	XR-NTX	Oral Naltrexone
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

Adverse Events

Time Frame	24 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	XR-NTX		Oral Naltrexone
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	--/--		--/--
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.
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

Limitations and Caveats

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
• EMail: peter.friedmann@va.gov

Publications of Results:

Friedmann PD, Mello D, Lonergan S, Bourgault C, O'Toole TP. Aversion to injection limits acceptability of extended-release naltrexone among homeless, alcohol-dependent patients. Subst Abus. 2013;34(2):94-6. doi: 10.1080/08897077.2012.763083.

• 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