NCT01751789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

5.1 years

First QC Date

December 14, 2012

Last Update Submit

January 3, 2019

Conditions

Illicit Opioid Drug Use

Keywords

illicit opioid drug usehealth service utilization

Outcome Measures

Primary Outcomes (2)

  • Illicit opioid use

    Illicit opioid use will be measured by self-report and by urine toxicology

    6 months

  • Health Service Utilization

    Health service utilization will be measured by self-report and medical chart review

    6 months

Study Arms (2)

Linkage

ACTIVE COMPARATOR

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

Behavioral: Linkage

Detoxification

PLACEBO COMPARATOR

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

Other: Treatment as Usual

Interventions

LinkageBEHAVIORAL
Linkage
Treatment as UsualOTHER
Detoxification

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSTAR

Fall River, Massachusetts, 02720, United States

Location

Related Publications (18)

  • 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.

    PMID: 32359671DERIVED

  • 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.

    PMID: 31952626DERIVED

  • 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.

    PMID: 31370978DERIVED

  • 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.

    PMID: 31140667DERIVED

  • 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.

    PMID: 30461441DERIVED

  • 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.

    PMID: 30384320DERIVED

  • 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.

    PMID: 30243418DERIVED

  • 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.

    PMID: 29680676DERIVED

  • 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.

    PMID: 29415853DERIVED

  • 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.

    PMID: 29407681DERIVED

  • 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.

    PMID: 28841495DERIVED

  • 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.

    PMID: 28692407DERIVED

  • 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.

    PMID: 28554602DERIVED

  • 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.

    PMID: 28505487DERIVED

  • 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.

    PMID: 28476275DERIVED

  • 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.

    PMID: 27182836DERIVED

  • 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.

    PMID: 26254317DERIVED

  • 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.

    PMID: 25171955DERIVED

MeSH Terms

Conditions

Patient Acceptance of Health Care

Interventions

Genetic LinkageTherapeutics

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 14, 2012

First Posted

December 18, 2012

Study Start

October 1, 2012

Primary Completion

November 1, 2017

Study Completion

August 1, 2018

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

US(1)