Trial Outcomes & Findings for Intermittent Naltrexone Among Polysubstance Users (NCT NCT01723384)

NCT ID: NCT01723384

Last Updated: 2019-04-23

Results Overview

Proportion of persons retained by study arm.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant
• Results posted on: 2019-04-23

Participant Flow

Participant milestones

Measure	Naltrexone Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks. Intermittent Oral Naltrexone	Placebo Intermittent oral placebo to be taken on an as-needed basis for 8 weeks Placebo
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Intermittent Naltrexone Among Polysubstance Users

Baseline characteristics by cohort

Measure	Naltrexone n=15 Participants Intermittent oral naltrexone to be taken on an as-needed basis for 8 weeks. Intermittent Oral Naltrexone	Placebo n=15 Participants Intermittent oral placebo to be taken on an as-needed basis for 8 weeks Placebo	Total n=30 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	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	43.7 years STANDARD_DEVIATION 10 • n=5 Participants	42.3 years STANDARD_DEVIATION 10 • n=7 Participants	43 years STANDARD_DEVIATION 9.3 • 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	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: proportions eligible and enrolled assessed on ongoing basis throughout the study, proportion of visits completed assessed bi-weekly for each participant; overall retention assessed over 2 month follow-up for each participant

Proportion of persons retained by study arm.

Outcome measures

Measure	Naltrexone n=15 Participants Naltrexone	Placebo n=15 Participants Placebo
Feasibility of Retaining Participants in Trial	100 percentage that completed study	86.7 percentage that completed study

PRIMARY outcome

Timeframe: 2 month follow-up

Mean number of pills taken weekly, as determined by recorded openings from an electronic monitoring device for study medication pill dispensers

Outcome measures

Measure	Naltrexone n=15 Participants Naltrexone	Placebo n=15 Participants Placebo
Acceptability to Taking Medication	2.2 number of wisepill openings by week Standard Deviation 1	1.9 number of wisepill openings by week Standard Deviation 1

PRIMARY outcome

Timeframe: 2 months

Frequency of Adverse Events, by arm

Outcome measures

Measure	Naltrexone n=15 Participants Naltrexone	Placebo n=15 Participants Placebo
Tolerability to Study Drug, as Measured by Adverse Events Upper respiratory tract infection	2 Count	4 Count
Tolerability to Study Drug, as Measured by Adverse Events Nausea	4 Count	2 Count
Tolerability to Study Drug, as Measured by Adverse Events Headaches	2 Count	1 Count

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Naltrexone n=15 participants at risk Naltrexone	Placebo n=15 participants at risk Placebo
General disorders Nausea	26.7% 4/15 • Number of events 4	13.3% 2/15 • Number of events 2
General disorders Headaches	13.3% 2/15 • Number of events 2	6.7% 1/15 • Number of events 1
Respiratory, thoracic and mediastinal disorders upper respiratory tract infection	13.3% 2/15 • Number of events 2	26.7% 4/15 • Number of events 4

Additional Information

Dr. Glenn-Milo Santos

San Francisco Department of Public Healt

Phone: 415-437-6231

Email: glenn-milo.santos@ucsf.edu

Results disclosure agreements

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