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
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder||Behavioral: distress tolerance training Other: treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
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
|Contact: Sandra Deitchfirstname.lastname@example.org|
|United States, Rhode Island|
|Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Kirsten Langdon 401-606-4198 email@example.com|
|Principal Investigator:||Kirsten Langdon, PhD||Rhode Island Hospital|