Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Illicit Opioid Drug Use |
Behavioral: Linkage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care |
- Illicit opioid use [ Time Frame: 6 months ] [ Designated as safety issue: No ]Illicit opioid use will be measured by self-report and by urine toxicology
- Health Service Utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]Health service utilization will be measured by self-report and medical chart review
| Estimated Enrollment: | 370 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Linkage
Participants will receive Suboxone during their inpatient detoxication and be given outpatient appointments to continue Suboxone treatment after completing inpatient detoxification
|
Behavioral: Linkage |
|
Placebo Comparator: Detoxification
Participants will receive Suboxone to detoxify from opioids and the standard treatment offered by the inpatient detoxification program
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Michael Stein, MD, Principal Investigator, Butler Hospital |
| ClinicalTrials.gov Identifier: | NCT01751789 History of Changes |
| Other Study ID Numbers: | DA034261 |
| Study First Received: | December 14, 2012 |
| Last Updated: | December 14, 2012 |
| Health Authority: | United States: National Institutes of Health |
Keywords provided by Butler Hospital:
|
illicit opioid drug use health service utilization |
Additional relevant MeSH terms:
|
Analgesics, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 19, 2013