Trial Outcomes & Findings for Pilot Study of Depot NTX in Homeless Veterans (NCT NCT01155869)

NCT ID: NCT01155869

Last Updated: 2014-07-17

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 7 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2014-07-17

Participant Flow

215 potential subjects were approached over a 16-month period of recruitment; only 15 agreed to be screen after hearing of study procedures.

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.

Participant milestones

Measure	XR-NTX Depot naltrexone (Vivitrol) 380 mg. IM monthly	Oral Naltrexone Naltrexone 50 mg tablet PO daily
Overall Study STARTED	3	4
Overall Study COMPLETED	0	3
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Measure	XR-NTX Depot naltrexone (Vivitrol) 380 mg. IM monthly	Oral Naltrexone Naltrexone 50 mg tablet PO daily
Overall Study Lost to Follow-up	3	1

Baseline Characteristics

Pilot Study of Depot NTX in Homeless Veterans

Baseline characteristics by cohort

Measure	XR-NTX n=3 Participants Depot naltrexone (Vivitrol) 380 mg. IM monthly	Oral Naltrexone n=4 Participants Naltrexone 50 mg tablet PO daily	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

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.

Outcome measures

Measure	XR-NTX n=3 Participants Depot naltrexone (Vivitrol) 380 mg. IM monthly	Oral Naltrexone n=4 Participants Naltrexone 50 mg tablet PO daily
Mean Weekly Self-reported Alcohol Consumption	0 standard drink Standard Deviation 0	65 standard drink Standard Deviation 10.6

SECONDARY outcome

Timeframe: 16 weeks

Percentage of total during-treatment study visits attended. This serves as a proxy for the number of months of treatment participation

Outcome measures

Measure	XR-NTX n=12 Visits Depot naltrexone (Vivitrol) 380 mg. IM monthly	Oral Naltrexone n=16 Visits Naltrexone 50 mg tablet PO daily
Treatment Participation	33.3 percentage of visits	87.5 percentage of visits

Adverse Events

XR-NTX

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Naltrexone

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	XR-NTX n=3 participants at risk Depot naltrexone (Vivitrol) 380 mg. IM monthly	Oral Naltrexone n=4 participants at risk Naltrexone 50 mg tablet PO daily
Investigations death	33.3% 1/3 • Number of events 1 • 24 weeks	0.00% 0/4 • 24 weeks

Other adverse events

Measure	XR-NTX n=3 participants at risk Depot naltrexone (Vivitrol) 380 mg. IM monthly	Oral Naltrexone n=4 participants at risk Naltrexone 50 mg tablet PO daily
Social circumstances Arrest	0.00% 0/3 • 24 weeks	25.0% 1/4 • Number of events 1 • 24 weeks
Gastrointestinal disorders Nausea/Vomiting	0.00% 0/3 • 24 weeks	25.0% 1/4 • Number of events 1 • 24 weeks

Additional Information

Peter Friedmann

Providence VA Medical Center

Phone: 401-273-7100

Email: peter.friedmann@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place