Clinical trial NCT01751789: Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care
Official title: Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Illicit Opioid Drug Use
Keywords: illicit opioid drug use
health service utilization
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 335
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether, for individuals in inpatient opioid detoxification, linking to outpatient Suboxone treatment increases treatment adherence and reduces relapse to illicit opioid use.

Detailed description: In this randomized trial, consenting individuals seeking inpatient opioid detoxification will be assigned to one of two groups. The first group will receive a tapering schedule of buprenorphine during inpatient detoxification to alleviate acute withdrawal symptoms, and referral to a community medical and substance abuse treatment providers (DETOX). The second group will also receive buprenorphine to relieve withdrawal symptoms, but will maintain a stable dose of buprenorphine through inpatient discharge and linkage to an appointment with a primary care provider within a week of discharge (LINKAGE). All participants complete study assessments at baseline, 1-month, 3-months and 6-months post-enrollment.

The SSTAR inpatient detoxification program based in Fall River, Massachusetts will serve as the recruitment site of this trial. SSTAR's program has 38 beds and is a 24-hour medically and psychiatrically supervised treatment facility that provides evaluation and withdrawal management. The SSTAR Family Healthcare Center is a 330 Federally Qualified facility also in Fall River that provides primary care and behavioral health services to residents of Community Health Network Area 25 (Fall River, Somerset, Swansea and Westport, Massachusetts). Dr. Bailey, Director of Research at SSTAR, will oversee the provision of buprenorphine treatment to study participants during detoxification and serve as liaison to the primary care providers at the Family Healthcare Center.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* opioid dependent;
* interested in initiating maintenance buprenorphine treatment;
* opioid positive on urine toxicology;
* willing to establish primary care with a buprenorphine-waivered physician at SSTAR.

Exclusion Criteria:

* Patients unable to provide informed consent due to acute illness, cognitive impairment, or psychosis;
* probation/parole requirements that might interfere with protocol participation (1% of SSTAR inpatients);
* inability to provide two contact persons to verify location;
* not able to complete assessments in English;
* currently enrolled in a methadone or suboxone maintenance program;
* plans to leave the area within the next 6 months;
* current DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, cocaine, or alcohol;
* current suicidality on the Modified Scale for Suicidal Ideation;
* chronic pain requiring ongoing opioid use or anticipated major painful event (significant surgical procedure) in the coming 6 months;
* pregnancy;
* history of allergic reaction to buprenorphine or naloxone.

Primary outcomes:
measure: Illicit opioid use
timeFrame: 6 months
measure: Health Service Utilization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fall River
country: United States
facility: SSTAR
state: Massachusetts
Study officials:
References:
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citation: Stein MD, Kenney SR, Anderson BJ, Conti MT, Bailey GL. Prescribed and non-prescribed gabapentin use among persons seeking inpatient opioid detoxification. J Subst Abuse Treat. 2020 Mar;110:37-41. doi: 10.1016/j.jsat.2019.12.007. Epub 2019 Dec 13.
citation: Stein MD, Kenney SR, Anderson BJ, Bailey GL. Perceptions about fentanyl-adulterated heroin and overdose risk reduction behaviors among persons seeking treatment for heroin use. J Subst Abuse Treat. 2019 Sep;104:144-147. doi: 10.1016/j.jsat.2019.07.006. Epub 2019 Jul 13.
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