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Digital Health Intervention for Medication-Assisted Treatment (iCOPE)

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ClinicalTrials.gov Identifier: NCT03842384
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : December 10, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Rhode Island Hospital

Brief Summary:
Medication-assisted treatment, including buprenorphine, is a first-line treatment for opioid use disorders; however, despite its many advantages, nearly 50% of patients are unable to achieve stabilization and long-term recovery. The proposed study will test whether a computer- and text message-delivered intervention can promote engagement in and adherence to buprenorphine among persons actively seeking outpatient medication-assisted treatment. This digital health intervention has the potential to improve treatment outcomes and prevent future overdose in a high-risk segment of the population.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Behavioral: distress tolerance training Other: treatment as usual Not Applicable

Detailed Description:
The state of Rhode Island has been especially impacted by the opioid epidemic with rates of overdose rising by 90% from 2011 to 2016. Medication-assisted treatment (MAT), the use of pharmacotherapy in combination with behavioral therapies, is associated with significant reductions in illicit opioid use. Buprenorphine, a partial opioid agonist, is one pharmacological option for MAT that is growing in popularity because of its more flexible administration through office-based programs. Despite its many advantages, nearly half of participants are unsuccessful in achieving buprenorphine stabilization. Distress tolerance (DT), defined as the perceived or actual ability to handle aversive physical or emotional states, is a transdiagnostic vulnerability factor implicated in the development and maintenance of substance use. Targeting DT during substance use treatment may improve outcomes by promoting the ability to persist in goal directed activity (e.g., abstinence) even when experiencing physical or emotional distress. Personalized feedback interventions (PFI) represent a promising method to effectively motivate engagement in and adherence to buprenorphine treatment. These interventions are generally brief, individually tailored, and have the potential to be delivered via mobile platforms (e.g., computers, text message). Specific aims of this research study include (1) the development, through formative evaluation, of an interactive computer- and text message-delivered PFI, that incorporates DT skills training, for persons actively seeking outpatient MAT (PFI-DT); and (2) pilot testing the feasibility, acceptability, and preliminary efficacy of PFI-DT for increasing motivation, abstinence, adherence, and retention to treatment compared to treatment as usual.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Digital Health Intervention for Medication-Assisted Treatment
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: distress tolerance training
computer- and text- message delivered intervention that enhances motivation through personalized feedback and increases tolerance of distress through skills training.
Behavioral: distress tolerance training
The proposed intervention will initially target motivational processes in combination with introductory strategies for managing physical and emotional distress through a single, brief, computer-delivered session followed by eight weeks of theoretically-informed text messages intended to enhance motivation and promote distress tolerance.

treatment as usual
standard outpatient buprenorphine treatment
Other: treatment as usual
standard outpatient buprenorphine treatment




Primary Outcome Measures :
  1. Self-Reported Buprenorphine Adherence [ Time Frame: Participants will be asked to report on daily use up to 1-, 4-, and 8- week following medication induction. ]
    The Timeline Follow-Back will be used to collect self-report data on daily buprenorphine adherence. Adherence is recorded as either 0 (prescribed dose not taken) or 1 (prescribed dose taken). Buprenorphine adherence will be operationalized as the percentage of days positive for buprenorphine administration.

  2. Self-Reported Illicit Substance Use [ Time Frame: Participants will be asked to report on daily use up to 1-, 4-, and 8- week following medication induction. ]
    The Timeline Follow-Back will be used to collect self-report data on daily illicit substance use. Illicit substance use will be recorded as either 0 (no illicit substance use) or 1 (illicit substance use). Illicit substance use will be operationalized as the percentage of days positive for drug use (separate by drug class).

  3. Biochemically Verified Buprenorphine Adherence [ Time Frame: Performed at 1-, 4-, and 8- week following medication induction. ]
    Urine samples will be collected and tested to confirm adherence to buprenorphine. A 5 ng/mL urine buprenorphine cutoff will be indicative of compliance with buprenorphine treatment.

  4. Biochemically Verified Illicit Substance Use [ Time Frame: Performed at 1-, 4-, and 8- week following medication induction. ]
    Urine samples will be collected and tested to confirm or deny use of other illicit substances.


Secondary Outcome Measures :
  1. Readiness Ruler [ Time Frame: 1-, 4-, 8-, and 12-weeks post medication induction. ]
    Brief assessment of a person's present motivational state relative to changing a specific behavior. In this study, the Readiness Ruler will assess participants' motivation to change use of illicit opioids. The ruler is based upon a likert scale ranging from 1 (Definitely NOT Ready to Change) to 10 (Definitely Ready to Change). Higher scores reflect greater motivation to change.

  2. Distress Tolerance Scale [ Time Frame: 1-, 4-, 8-, and 12-weeks post medication induction. ]
    The Distress Tolerance Scale is a 15-item self-report measure in which respondents indicate, on a 5-point Likert-type scale (1 = strongly agree to 5 = strongly disagree), the extent to which they can experience and withstand distressing psychological states. Higher total scores reflect greater ability to tolerate distress. The total score is computed as a mean, with a possible range of 1-5.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18+ years of age; current DSM-5 Opioid Use Disorder; interest in engaging in MAT, including the use of buprenorphine; and, access to cell phone with text message capability

Exclusion Criteria:

  • active suicidality and/or psychosis that would interfere with the ability to participate in the intervention; not fluent in English; limited mental capacity or inability to provide informed written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842384


Contacts
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Contact: Sandra Deitch 401-444-8556 ora@lifespan.org

Locations
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United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Kirsten Langdon    401-606-4198    kirsten.langdon@lifespan.org   
Sponsors and Collaborators
Rhode Island Hospital
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kirsten Langdon, PhD Rhode Island Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT03842384    
Other Study ID Numbers: K23DA046482 ( U.S. NIH Grant/Contract )
K23DA046482 ( U.S. NIH Grant/Contract )
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No