Trial Outcomes & Findings for CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery (NCT NCT01587196)

NCT ID: NCT01587196

Last Updated: 2024-10-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 72 participants
• Primary outcome timeframe: three months
• Results posted on: 2024-10-15

Participant Flow

50 individuals were lost to attrition. 4 individuals withdrew from the study.

Participant milestones

Measure	Naltrexone Intervention Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks. Vivitrol: There are monthly injections of depot naltrexone for 3 months.
Overall Study STARTED	72
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	54

Reasons for withdrawal

Measure	Naltrexone Intervention Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks. Vivitrol: There are monthly injections of depot naltrexone for 3 months.
Overall Study Lost to Follow-up	50
Overall Study Withdrawal by Subject	4

Baseline Characteristics

CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery

Baseline characteristics by cohort

Measure	Naltrexone Intervention n=72 Participants Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks. Vivitrol: There are monthly injections of depot naltrexone for 3 months.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	67 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	56 Participants n=5 Participants
Race/Ethnicity, Customized Race · African American	11 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Alaskan Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian/Pacific Islander	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic (Mexican)	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic (Puerto Rican)	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic (Cuban)	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: three months

Population: Individuals were tested for presence of opioids: buprenorphine, methadone, opioids, and oxycontin within their urine toxicology

Outcome measures

Measure	Naltrexone Intervention n=72 Participants Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks. Vivitrol: There are monthly injections of depot naltrexone for 3 months.
Illicit-positive Urines During Treatment and Follow-up Injection One · Buprenorphine	0 Participants
Illicit-positive Urines During Treatment and Follow-up Injection One · Methadone	0 Participants
Illicit-positive Urines During Treatment and Follow-up Injection One · Opioids	1 Participants
Illicit-positive Urines During Treatment and Follow-up Injection One · Oxycontin	1 Participants
Illicit-positive Urines During Treatment and Follow-up Injection One · Negative Urine Test	70 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Two · Buprenorphine	2 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Two · Methadone	0 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Two · Opioids	1 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Two · Oxycontin	2 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Two · Negative Urine Test	67 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Three · Buprenorphine	0 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Three · Methadone	0 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Three · Opioids	1 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Three · Oxycontin	0 Participants
Illicit-positive Urines During Treatment and Follow-up Injection Three · Negative Urine Test	71 Participants

Adverse Events

Naltrexone Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Langleben, MD

University of Pennsylvania

Phone: 215-760-7067

Email: langlebe@pennmedicine.upenn.edu

Results disclosure agreements

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