Opioid Use DisorderBundlingNCT02712034
Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth
A study testing MAT + A-CHESS and MAT in people with Opioid Use Disorder, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The primary aim of this study is to measure and explain the impact on long-term opioid use when medication-assisted treatment (MAT) is bundled with an evidence-based mobile-health system (A-CHESS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- MAT + A-CHESS and MAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 417 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2016to 8 Apr 2020
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- are 18+ years old;
- meet criteria for opioid use disorders of at least moderate severity (4 or 5 DSM-V criteria);
- Are currently taking medication-assisted treatment (MAT) as part of their standard clinical care;
- have no acute medical problem requiring immediate inpatient treatment;
- have no history of psychotic disorders, though those with other co-morbid psychopathology (mood disorders, anxiety, other substance use disorders) will be eligible;
- are willing to participate in a randomized clinical trial;
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- provide the name, verified telephone number, and address of at least 2 contacts willing to help locate the patient, if necessary, during follow-up;
- are able to read and write in English;
- are not pregnant;
- are willing to share health-related data with primary care clinicians; and
- are, at study intake, abstinent from opioids for at least 1 week and no longer than 2 months, except for medications used to treat the disorder (e.g., methadone).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Access Community Health Centers
Madison, Wisconsin, 53713
About this study
The primary aim of this study is to measure and explain the impact on long-term opioid use when medication-assisted treatment (MAT) is bundled with an evidence-based mobile-health system (A-CHESS).
- Conditions
- Opioid Use Disorder
- Being tested
- MAT + A-CHESS, MAT
- Keywords
- Medication-assisted treatment (MAT), Buprenorphine, Methadone, Naltrexone
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAT + A-CHESSBehavioural
Subjects randomized to MAT + A-CHESS will receive MAT plus the A-CHESS recovery support system which provides:
- Self-directed, interactive modules that teach basic recovery support, harm-reduction, and psychosocial functioning skills.
- The latest information about addiction and recovery support, monitoring prompts, and peer and family support.
- Advice on where to go for help and on how to make the best use of health and human services; and
- A way to talk with experts in the area of addiction and other study participants by sending anonymous messages in the A-CHESS discussion groups.
- A way to keep your health care team up to date through reports based on information entered into A-CHESS (i.e. alcohol and drug use, depression, MAT side effects).
MATOther
Patients will receive treatment consisting of a recovery plan, appropriate pharmacology, routine urine screens, and regularly scheduled behavioral interventions, such as monthly group counseling sessions or sessions with a recovery coach. "Appropriate pharmacology" may include methadone; naltrexone; buprenorphine; and in the case of overdose, naloxone; and other medications and combinations of medications as part of the patient's standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Medication-assisted treatment (MAT) | Placebo comparator | Patients will receive standard medication-assisted treatment (MAT) as prescribed by their health care provider. Receives: Other: MAT |
| MAT + A-CHESS | Experimental | Patients in the MAT + A-CHESS arm will receive MAT as described plus the A-CHESS recovery support system via a smartphone. Receives: Behavioral: MAT + A-CHESS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use
Detect the difference in illicit opioid use between patients who have MAT + A-CHESS vs. MAT alone.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start21 Apr 2016
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Street Treatment and Resources (SSTAR), Gosnold on Cape Cod, ARC Community Services, Inc., National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- David H Gustafson, PhD, Principal investigator, UW Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712034
- Sponsor's protocol ID
- 2015-1418
- Other IDs
- 1R01DA040449-01, A195010, INDUSTRIAL ENGR\CHESS PROG
- Acronym
- Bundling
- Status last verified
- Apr 2020
- First submitted
- 14 Mar 2016
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gustafson DH, Landucci G, Vjorn OJ, Gicquelais RE, Goldberg SB, Johnston DC, Curtin JJ, Bailey GL, Shah DV, Pe-Romashko K, Gustafson DH. Effects of Bundling Medication for Opioid Use Disorder With an mHealth Intervention Targeting Addiction: A Randomized Clinical Trial. Am J Psychiatry. 2024 Feb 1;181(2):115-124. doi: 10.1176/appi.ajp.20230055. Epub 2023 Oct 4.
PubMed 37789744Hochstatter KR, Gustafson DH Sr, Landucci G, Pe-Romashko K, Cody O, Maus A, Shah DV, Westergaard RP. Effect of an mHealth Intervention on Hepatitis C Testing Uptake Among People With Opioid Use Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 22;9(2):e23080. doi: 10.2196/23080.
PubMed 33616545Hochstatter KR, Gustafson DH Sr, Landucci G, Pe-Romashko K, Maus A, Shah DV, Taylor QA, Gill EK, Miller R, Krechel S, Westergaard RP. A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Aug 1;8(8):e12620. doi: 10.2196/12620.
PubMed 31373273Gustafson DH Sr, Landucci G, McTavish F, Kornfield R, Johnson RA, Mares ML, Westergaard RP, Quanbeck A, Alagoz E, Pe-Romashko K, Thomas C, Shah D. The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial. Trials. 2016 Dec 12;17(1):592. doi: 10.1186/s13063-016-1726-1.
PubMed 27955689
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Opioid Use of Bundling Medication-assisted Treatment With mHealth
- ClinicalTrials.gov ID
- NCT02712034
- Acronym / sponsor ID
- Bundling / 2015-1418
- Conditions
- Opioid Use Disorder
- Keywords
- Medication-assisted treatment (MAT), Buprenorphine, Methadone, Naltrexone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Stanley Street Treatment and Resources (SSTAR), Gosnold on Cape Cod, ARC Community Services, Inc., National Institute on Drug Abuse (NIDA)
- Study start
- 21 Apr 2016 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 17 Mar 2016 (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 primary aim of this study is to measure and explain the impact on long-term opioid use when medication-assisted treatment (MAT) is bundled with an evidence-based mobile-health system (A-CHESS).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medication-assisted treatment (MAT) | Placebo comparator | Other: MATPatients will receive standard medication-assisted treatment (MAT) as prescribed by their health care provider. |
| MAT + A-CHESS | Experimental | Behavioral: MAT + A-CHESSPatients in the MAT + A-CHESS arm will receive MAT as described plus the A-CHESS recovery support system via a smartphone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- are 18+ years old;
- meet criteria for opioid use disorders of at least moderate severity (4 or 5 DSM-V criteria);
- Are currently taking medication-assisted treatment (MAT) as part of their standard clinical care;
- have no acute medical problem requiring immediate inpatient treatment;
- have no history of psychotic disorders, though those with other co-morbid psychopathology (mood disorders, anxiety, other substance use disorders) will be eligible;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| MAT + A-CHESSSubjects randomized to MAT + A-CHESS will receive MAT plus the A-CHESS recovery support system which provides: 1. Self-directed, interactive modules that teach basic recovery support, harm-reduction, and psychosocial functioning skills. 2. The latest information about addiction and recovery support, monitoring prompts, and peer and family support. 3. Advice on where to go for help and on how to make the best use of health and human services; and 4. A way to talk with experts in the area of addiction and other study participants by sending anonymous messages in the A-CHESS discussion groups. 5. A way to keep your health care team up to date through reports based on information entered into A-CHESS (i.e. alcohol and drug use, depression, MAT side effects). | Behavioural | MAT + A-CHESS |
| MATPatients will receive treatment consisting of a recovery plan, appropriate pharmacology, routine urine screens, and regularly scheduled behavioral interventions, such as monthly group counseling sessions or sessions with a recovery coach. "Appropriate pharmacology" may include methadone; naltrexone; buprenorphine; and in the case of overdose, naloxone; and other medications and combinations of medications as part of the patient's standard clinical care. | Other | Medication-assisted treatment (MAT) |
Primary outcome
Opioid use
Time frame: 24 months
Detect the difference in illicit opioid use between patients who have MAT + A-CHESS vs. MAT alone.
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 14 Apr 2020.
- Derived from this study: PubMed 37789744Gustafson DH, Landucci G, Vjorn OJ, Gicquelais RE, Goldberg SB, Johnston DC, Curtin JJ, Bailey GL, Shah DV, Pe-Romashko K, Gustafson DH. Effects of Bundling Medication for Opioid Use Disorder With an mHealth Intervention Targeting Addiction: A Randomized Clinical Trial. Am J Psychiatry. 2024 Feb 1;181(2):115-124. doi: 10.1176/appi.ajp.20230055. Epub 2023 Oct 4.
- Derived from this study: PubMed 33616545Hochstatter KR, Gustafson DH Sr, Landucci G, Pe-Romashko K, Cody O, Maus A, Shah DV, Westergaard RP. Effect of an mHealth Intervention on Hepatitis C Testing Uptake Among People With Opioid Use Disorder: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Feb 22;9(2):e23080. doi: 10.2196/23080.
- Derived from this study: PubMed 31373273Hochstatter KR, Gustafson DH Sr, Landucci G, Pe-Romashko K, Maus A, Shah DV, Taylor QA, Gill EK, Miller R, Krechel S, Westergaard RP. A Mobile Health Intervention to Improve Hepatitis C Outcomes Among People With Opioid Use Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Aug 1;8(8):e12620. doi: 10.2196/12620.
- Derived from this study: PubMed 27955689Gustafson DH Sr, Landucci G, McTavish F, Kornfield R, Johnson RA, Mares ML, Westergaard RP, Quanbeck A, Alagoz E, Pe-Romashko K, Thomas C, Shah D. The effect of bundling medication-assisted treatment for opioid addiction with mHealth: study protocol for a randomized clinical trial. Trials. 2016 Dec 12;17(1):592. doi: 10.1186/s13063-016-1726-1.
- Individual participant dataSharing planned: No
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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.
David H Gustafson, PhD principal investigator
UW Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAT + A-CHESS and MAT in people with Opioid Use Disorder, run by University of Wisconsin, Madison 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 11 inclusion and 0 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 14 Apr 2020. 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?
Opioid use (time frame: 24 months). 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 NCT02712034, which also lists 4 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 14 Apr 2020.