Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care

NCT ID: NCT01751789

Last Updated: 2019-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Illicit Opioid Drug Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Linkage

Participants will receive Suboxone during their inpatient detoxication and be given outpatient appointments to continue Suboxone treatment after completing inpatient detoxification

Group Type ACTIVE_COMPARATOR

Linkage

Intervention Type BEHAVIORAL

Detoxification

Participants will receive Suboxone to detoxify from opioids and the standard treatment offered by the inpatient detoxification program

Group Type PLACEBO_COMPARATOR

Treatment as Usual

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Linkage

Intervention Type BEHAVIORAL

Treatment as Usual

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Stein, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SSTAR

Fall River, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Christopher PP, Anderson B, Stein MD. Comparing views on civil commitment for drug misuse and for mental illness among persons with opioid use disorder. J Subst Abuse Treat. 2020 Jun;113:107998. doi: 10.1016/j.jsat.2020.107998. Epub 2020 Mar 5.

Reference Type DERIVED
PMID: 32359671 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31952626 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31370978 (View on PubMed)

Pivovarova E, Stein MD. In their own words: language preferences of individuals who use heroin. Addiction. 2019 Oct;114(10):1785-1790. doi: 10.1111/add.14699. Epub 2019 Jul 11.

Reference Type DERIVED
PMID: 31140667 (View on PubMed)

Kenney SR, Anderson BJ, Bailey GL, Stein MD. Drug Use-Related Normative Misperceptions and Behaviors Among Persons Seeking Heroin Withdrawal Management. J Addict Med. 2019 May/Jun;13(3):215-219. doi: 10.1097/ADM.0000000000000482.

Reference Type DERIVED
PMID: 30461441 (View on PubMed)

Christopher PP, Anderson B, Stein MD. Civil commitment experiences among opioid users. Drug Alcohol Depend. 2018 Dec 1;193:137-141. doi: 10.1016/j.drugalcdep.2018.10.001. Epub 2018 Oct 18.

Reference Type DERIVED
PMID: 30384320 (View on PubMed)

Kenney SR, Anderson BJ, Bailey GL, Stein MD. Buprenorphine treatment formulations: Preferences among persons in opioid withdrawal management. J Subst Abuse Treat. 2018 Nov;94:55-59. doi: 10.1016/j.jsat.2018.08.011. Epub 2018 Aug 28.

Reference Type DERIVED
PMID: 30243418 (View on PubMed)

Stein MD, Kenney SR, Anderson BJ, Bailey GL. Loaded: Gun involvement among opioid users. Drug Alcohol Depend. 2018 Jun 1;187:205-211. doi: 10.1016/j.drugalcdep.2018.03.015. Epub 2018 Apr 16.

Reference Type DERIVED
PMID: 29680676 (View on PubMed)

Kenney SR, Anderson BJ, Conti MT, Bailey GL, Stein MD. Expected and actual fentanyl exposure among persons seeking opioid withdrawal management. J Subst Abuse Treat. 2018 Mar;86:65-69. doi: 10.1016/j.jsat.2018.01.005. Epub 2018 Jan 4.

Reference Type DERIVED
PMID: 29415853 (View on PubMed)

Kenney SR, Anderson BJ, Stein MD. Drinking to cope mediates the relationship between depression and alcohol risk: Different pathways for college and non-college young adults. Addict Behav. 2018 May;80:116-123. doi: 10.1016/j.addbeh.2018.01.023. Epub 2018 Feb 4.

Reference Type DERIVED
PMID: 29407681 (View on PubMed)

Stein MD, Conti MT, Kenney S, Anderson BJ, Flori JN, Risi MM, Bailey GL. Adverse childhood experience effects on opioid use initiation, injection drug use, and overdose among persons with opioid use disorder. Drug Alcohol Depend. 2017 Oct 1;179:325-329. doi: 10.1016/j.drugalcdep.2017.07.007. Epub 2017 Aug 5.

Reference Type DERIVED
PMID: 28841495 (View on PubMed)

Stein MD, Flori JN, Risi MM, Conti MT, Anderson BJ, Bailey GL. Overdose history is associated with postdetoxification treatment preference for persons with opioid use disorder. Subst Abus. 2017 Oct-Dec;38(4):389-393. doi: 10.1080/08897077.2017.1353570. Epub 2017 Jul 10.

Reference Type DERIVED
PMID: 28692407 (View on PubMed)

Kenney SR, Anderson BJ, Bailey GL, Stein MD. The relationship between diversion-related attitudes and sharing and selling buprenorphine. J Subst Abuse Treat. 2017 Jul;78:43-47. doi: 10.1016/j.jsat.2017.04.017. Epub 2017 Apr 27.

Reference Type DERIVED
PMID: 28554602 (View on PubMed)

Kenney SR, Bailey GL, Anderson BJ, Stein MD. Heroin refusal self-efficacy and preference for medication-assisted treatment after inpatient detoxification. Addict Behav. 2017 Oct;73:124-128. doi: 10.1016/j.addbeh.2017.05.009. Epub 2017 May 9.

Reference Type DERIVED
PMID: 28505487 (View on PubMed)

Stein MD, Anderson BJ, Kenney SR, Bailey GL. Beliefs about the consequences of using benzodiazepines among persons with opioid use disorder. J Subst Abuse Treat. 2017 Jun;77:67-71. doi: 10.1016/j.jsat.2017.03.002. Epub 2017 Mar 9.

Reference Type DERIVED
PMID: 28476275 (View on PubMed)

Schonbrun YC, Anderson BJ, Johnson JE, Stein MD. Feasibility of a Supportive Other Intervention for Opiate-Dependent Patients Entering Inpatient Detoxification. J Psychoactive Drugs. 2016 Jul-Aug;48(3):181-6. doi: 10.1080/02791072.2016.1179377. Epub 2016 May 16.

Reference Type DERIVED
PMID: 27182836 (View on PubMed)

Stein MD, Anderson BJ, Bailey GL. Preferences for Aftercare Among Persons Seeking Short-Term Opioid Detoxification. J Subst Abuse Treat. 2015 Dec;59:99-103. doi: 10.1016/j.jsat.2015.07.002. Epub 2015 Jul 14.

Reference Type DERIVED
PMID: 26254317 (View on PubMed)

Stein MD, Anderson BJ, Thurmond P, Bailey GL. Comparing the life concerns of prescription opioid and heroin users. J Subst Abuse Treat. 2015 Jan;48(1):43-8. doi: 10.1016/j.jsat.2014.07.001. Epub 2014 Jul 11.

Reference Type DERIVED
PMID: 25171955 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DA034261

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Distress Tolerance and Buprenorphine
NCT01556087 COMPLETED PHASE3