Trial Outcomes & Findings for Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings (NCT NCT02978417)

NCT ID: NCT02978417

Last Updated: 2020-06-16

Results Overview

Any new arrests during the 12-month study period. This information will be collected from administrative records.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 14 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-06-16

Participant Flow

Community treatment provider Fellowship Health Resources (FHR) prescreened 19 people as eligible. Two declined to participate and 3 were terminated from court and lost eligibility, leaving 14 potential subjects.

Fourteen subjects consented to be in the study and completed a baseline interview. Four were terminated from court thereby losing eligibility, so they were not randomized.

Participant milestones

Measure	Vivitrol All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Overall Study STARTED	5	5
Overall Study COMPLETED	3	3
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Vivitrol All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Feasibility Study of Extended-release Naltrexone (Vivitrol) in Drug Court Settings

Baseline characteristics by cohort

Measure	Vivitrol n=5 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.	Total n=10 Participants Total of all reporting groups
Age, Continuous	36.2 years STANDARD_DEVIATION 9.4 • n=5 Participants	37.4 years STANDARD_DEVIATION 13.4 • n=7 Participants	36.8 years STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Any new arrests during the 12-month study period. This information will be collected from administrative records.

Outcome measures

Measure	Vivitrol n=5 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Number of Participants With New Arrests	2 Participants	2 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Any new incarceration during the 12-month study period. This information will be collected from administrative records.

Outcome measures

Measure	Vivitrol n=5 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Number of Participants With New Incarcerations	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Number of times a client had a positive drug screen. This information will be collected from administrative records.

Outcome measures

Measure	Vivitrol n=5 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Number of Positive Drug Screens	2 positive drug screens Standard Deviation 1.87	2.8 positive drug screens Standard Deviation 2.59

SECONDARY outcome

Timeframe: 12 months

Population: Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Number of sanctions imposed by the court (e.g., brief stays in jail). This information will be collected from administrative records.

Outcome measures

Measure	Vivitrol n=5 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Number of Sanctions Imposed by the Court	1.8 sanctions Standard Deviation 1.30	3.6 sanctions Standard Deviation 3.91

SECONDARY outcome

Timeframe: 12 months

Population: Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Number of missed court appointments during the 12-month study period. This information will be collected from administrative records.

Outcome measures

Measure	Vivitrol n=5 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Number of Missed Court Appointments	0 missed court appointments Standard Deviation 0	0 missed court appointments Standard Deviation 0

SECONDARY outcome

Timeframe: 12 months

Population: Some subjects in the oral naltrexone arm received Vivitrol through other means. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Number of Vivitrol injections from either arm of study. This information will be collected from administrative records.

Outcome measures

Measure	Vivitrol n=5 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Vivitrol Participation	3.8 Vivitrol injections Standard Deviation 4.97	1.4 Vivitrol injections Standard Deviation 1.67

SECONDARY outcome

Timeframe: 12 months

Population: Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Number of oral naltrexone monthly prescriptions from either arm of study. This information will be collected from administrative records.

Outcome measures

Measure	Vivitrol n=5 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Treatment Participation (Non-Vivitrol)	0.2 oral naltrexone monthly prescriptions Standard Deviation 0.45	1.6 oral naltrexone monthly prescriptions Standard Deviation 2.61

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Data not collected.

Subjective assessment of medical status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Subjective assessment of employment opportunities collected via interviews at baseline and approximately six months.

Outcome measures

Measure	Vivitrol n=3 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=3 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Number of Participants Who Reported Improvement in Subjective Functioning: Employment/Support Status	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Subjective assessment of alcohol/drug use in past 30 days collected via interviews at baseline and approximately six months.

Outcome measures

Measure	Vivitrol n=3 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=3 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Number of Participants Who Reported Improvement in Substance Use	3 Participants	1 Participants

SECONDARY outcome

Timeframe: approximately 6 months

Population: Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Subjective assessment of illegal behavior using the question, "Have you done anything that was against the law in the last 30 days?" collected via interviews approximately six months after baseline.

Outcome measures

Measure	Vivitrol n=3 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=3 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Number of Participants Who Reported Illegal Behavior	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, approximately 6 months

Population: Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Subjective assessment of family and social relationships using a single question about satisfaction with relationships over the past 30 days collected via interviews at baseline and approximately six months.

Outcome measures

Measure	Vivitrol n=3 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=3 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Number of Participants Who Reported Improvement in Subjective Functioning: Family/Social Relationships	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, approximately 6 months

Population: Data not collected.

Subjective assessment of psychiatric status using the Addiction Severity Index (ASI) Lite (a single measure with multiple domains) collected via interviews at baseline and approximately six months.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Approximately 6 months

Population: Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Reported as average of 12-item treatment satisfaction score at approximately six months. A score of 5 indicates strong agreement with positive statements about treatment satisfaction; a score of 0 indicates strong disagreement.

Outcome measures

Measure	Vivitrol n=3 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=3 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Treatment Satisfaction Score	4.53 score on a scale Standard Deviation 0.75	4.83 score on a scale Standard Deviation 0.29

SECONDARY outcome

Timeframe: Baseline, approximately 6 months

Population: Subjects who completed the 6-month assessment. Due to the nature of this pilot phase study, all statistical analyses are considered exploratory.

Change in MAT attitudes from baseline to follow-up. The average score of 4 questions about MAT for substance use disorder were calculated at baseline and follow-up, and the average score at baseline was subtracted from the average score at follow-up. The averages are based on questions for which a score of 5 indicates strong agreement with statements about MAT; a score of 1 indicates strong disagreement with such statements.

Outcome measures

Measure	Vivitrol n=3 Participants All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=3 Participants Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Change in Medication-assisted Treatment (MAT) Attitudes	0.11 score on a scale Standard Deviation 0.59	0.08 score on a scale Standard Deviation 0.14

Adverse Events

Vivitrol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Oral Naltrexone

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vivitrol n=5 participants at risk All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 participants at risk Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Injury, poisoning and procedural complications Drug overdose (unrelated)	0.00% 0/5 • Approximately 6 months.	20.0% 1/5 • Approximately 6 months.

Other adverse events

Measure	Vivitrol n=5 participants at risk All drug court clients in the pilot RCT will receive standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Participants randomized to Vivitrol® will receive standard treatment along with monthly Vivitrol® injections administered by study staff at outpatient visits. Vivitrol® is an extended-release injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent. The recommended dose of Vivitrol® is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection (see Links section of PRS for more information about Vivitrol). Naltrexone for extended-release injectable suspension: Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12	Oral Naltrexone n=5 participants at risk Subjects randomized to oral naltrexone in addition to standard psychosocial treatment for opioid dependence from FHR as part of their drug court program participation. Oral naltrexone is the daily tablet formulation naltrexone that carries the same risks and benefits as the long-acting injectable formulation (Vivitrol®), except it does not have any of the risks related to injection (discomfort, potential for infection). Oral naltrexone is administered and provided by FHR to interested and eligible clients as part of the range of their usual care services. Oral naltrexone: Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
Social circumstances Incarceration >5 days	40.0% 2/5 • Approximately 6 months.	40.0% 2/5 • Approximately 6 months.

Additional Information

Michele Easter, Ph.D.

Duke University

Phone: 919-385-0862

Email: michele.easter@duke.edu

Results disclosure agreements

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