NCT04505540: STAR

Start Treatment and Recovery for Opioid Use Disorder

Completed NA Results posted Last updated 11 December 2023

What this trial tests

NA trial testing Bridge Clinic in Opioid-use Disorder in 104 participants. Completed in 31 October 2022.

Timeline

30 September 2019

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	University of Vermont
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	104
Start date	30 September 2019
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	1 location across United States

Drugs / interventions tested

• Bridge Clinic

Conditions studied

• Opioid-use Disorder — all drugs for Opioid-use Disorder →
• Mental Disorder — all drugs for Mental Disorder →
• Opioid Medication Assisted Treatment — all drugs for Opioid Medication Assisted Treatment →

Sponsor

University of Vermont

Who can join

18 and older, any sex, with Opioid-use Disorder or Mental Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Self-reported Treatment Retention Primary · 1 week

Self-reported enrollment in treatment for opioid use disorder after 1 week

Group	Value	95% CI
Bridge Clinic	51

Number of Participants With Self-reported Treatment Retention Primary · 3 months

Self-reported enrollment in treatment for opioid use disorder after 3 months

Group	Value	95% CI
Bridge Clinic	49

Number of Participants With Self-reported Treatment Retention Primary · 6 months

Self-reported enrollment in treatment for opioid use disorder after 6 months

Group	Value	95% CI
Bridge Clinic	51

Number of Participants With Illicit Opioid Use Secondary · 1 week

Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.

Group	Value	95% CI
Bridge Clinic	20

Number of Participants With Illicit Opioid Use Secondary · 3 months

Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.

Group	Value	95% CI
Bridge Clinic	14

Number of Participants With Illicit Opioid Use Secondary · 6 months

Urine analyzed for opioids (buprenorphine, methadone, oxycodone, hydrocodone, hydromorphone, heroin, fentanyl) and other drugs (cocaine, amphetamines, benzodiazepines, cannabinoids) via enzyme multiplied immunoassay. Note buprenorphine and methadone positive results not treated as illicit.

Group	Value	95% CI
Bridge Clinic	1

Sponsor's own description

The purpose of this study is 1) to evaluate whether emergency department-initiated medically assisted treatment with Buprenorphine/Naloxone in patients presenting with opioid use disorder will produce positive outcomes at 1 week, 3 months and 6 months after treatment initiation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.