Illicit Opioid Drug UseNCT01751789
Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care
A study testing Linkage and Treatment as Usual in people with Illicit Opioid Drug Use, run by Butler Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Illicit Opioid Drug Use
- What is being tested?
- Linkage and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 335 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Illicit Opioid Drug Use
- Being tested
- Linkage, Treatment as Usual
- Keywords
- illicit opioid drug use, health service utilization
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinkageBehavioural
Treatment as UsualOther
| Study group | Role | What they receive |
|---|---|---|
| Linkage | Active comparator | Participants will receive Suboxone during their inpatient detoxication and be given outpatient appointments to continue Suboxone treatment after completing inpatient detoxification Receives: Behavioral: Linkage |
| Detoxification | Placebo comparator | Participants will receive Suboxone to detoxify from opioids and the standard treatment offered by the inpatient detoxification program Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illicit opioid use
Illicit opioid use will be measured by self-report and by urine toxicology
Measured: 6 months
Health Service Utilization
Health service utilization will be measured by self-report and medical chart review
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Illicit Opioid Drug UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751789
- Sponsor's protocol ID
- DA034261
- Status last verified
- Jan 2019
- First submitted
- 14 Dec 2012
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32359671Stein 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.
PubMed 31952626Stein 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.
PubMed 31370978Pivovarova 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.
PubMed 31140667Kenney 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.
PubMed 30461441Christopher 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.
PubMed 30384320Kenney 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.
PubMed 30243418Stein 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.
PubMed 29680676Kenney 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.
PubMed 29415853Kenney 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.
PubMed 29407681Stein 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.
PubMed 28841495Stein 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.
PubMed 28692407Kenney 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.
PubMed 28554602Kenney 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.
PubMed 28505487Stein 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.
PubMed 28476275
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Opioid Dependent Patients From Inpatient Detoxification to Primary Care
- ClinicalTrials.gov ID
- NCT01751789
- Acronym / sponsor ID
- DA034261
- Conditions
- Illicit Opioid Drug Use
- Keywords
- illicit opioid drug use, health service utilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 18 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linkage | Active comparator | Behavioral: LinkageParticipants will receive Suboxone during their inpatient detoxication and be given outpatient appointments to continue Suboxone treatment after completing inpatient detoxification |
| Detoxification | Placebo comparator | Other: Treatment as UsualParticipants will receive Suboxone to detoxify from opioids and the standard treatment offered by the inpatient detoxification program |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linkage | Behavioural | Linkage |
| Treatment as Usual | Other | Detoxification |
Primary outcome
Illicit opioid use
Time frame: 6 months
Illicit opioid use will be measured by self-report and by urine toxicology
Health Service Utilization
Time frame: 6 months
Health service utilization will be measured by self-report and medical chart review
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Derived from this study: PubMed 32359671Christopher 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.
- Derived from this study: PubMed 31952626Stein 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.
- Derived from this study: PubMed 31370978Stein 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.
- Derived from this study: PubMed 31140667Pivovarova 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.
- Derived from this study: PubMed 30461441Kenney 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.
- Derived from this study: PubMed 30384320Christopher 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.
- Derived from this study: PubMed 30243418Kenney 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.
- Derived from this study: PubMed 29680676Stein 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.
- Derived from this study: PubMed 29415853Kenney 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.
- Derived from this study: PubMed 29407681Kenney 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.
- Derived from this study: PubMed 28841495Stein 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.
- Derived from this study: PubMed 28692407Stein 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linkage and Treatment as Usual in people with Illicit Opioid Drug Use, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illicit opioid use (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01751789, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.