Treatment Outcomes Among Patients With Prescription Narcotic Drug Use Disorder (TAPE)
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|ClinicalTrials.gov Identifier: NCT03713983|
Recruitment Status : Recruiting
First Posted : October 22, 2018
Last Update Posted : November 25, 2019
|Condition or disease||Intervention/treatment|
|Drug Use Disorders||Other: Observational study|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||81 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Characteristics of and Treatment Outcomes Among Patients With Prescription Narcotic Drug Use Disorder: a Naturalistic Cohort Study|
|Actual Study Start Date :||October 23, 2018|
|Estimated Primary Completion Date :||December 31, 2029|
|Estimated Study Completion Date :||December 31, 2029|
- Other: Observational study
- Change in prescription narcotic drug use [ Time Frame: 6-, 12- and 24-month follow-up or at last visit; 10-year follow-up. ]Change in dosage of prescription narcotic drugs
- Prescription narcotic drug abstinence [ Time Frame: 6-, 12- and 24-month follow-up or at last visit ]Measured by drug testing and self-reported substance use
- Retention in treatment [ Time Frame: 6-, 12- and 24-month follow-up or at last visit ]Data collected from scheduled visit
- Diagnoses of substance use disorder(s) [ Time Frame: 6-, 12-, and 24-month follow-up ]Number of participants with diagnoses of substance use disorder according to ICD-10
- Self-reported substance use [ Time Frame: 6-, 12-, and 24 month follow-up ]self-reported data using standard question in ASI
- Psychiatric comorbidity [ Time Frame: 6-, 12-, and 24-month follow-up ]Number of participants with psychiatric diagnoses according to ICD-10
- Personality traits [ Time Frame: 6-, 12-, and 24-month follow-ups ]SCID-2 Structured Clinical Interview for DSM-IV-Axis 2 Disorders, screening
- Insomnia [ Time Frame: 6-, 12-, and 24-month follow-up ]Insomnia Severity Index (ISI)
- Pain Scale [ Time Frame: 6-, 12-, and 24-month follow-up ]The PROMIS pain interference - Short form 4a (PROMIS-PI SF 4a), is a four-item questionnaire measuring the extent pain interferes with functioning in daily life. Items are rated on a five-point scale ranging from "not at all" to "very much". Summed scores range from 4-20, higher scores indicating greater pain interference. The scale is recommended by the National Institute of Drug Abuse (NIDA).
- Quality of life, including self-rated health [ Time Frame: 6-, 12-, and 24-month follow-up ]Measured by EuroQol 5D (EQ-5D), a two-part health index. Part one covers self-rated problems in five domains: mobility, self-care, everyday activities, pain/discomfort, and anxiety/depression. Each domain is rated on a five-level scale that indicates no problems to extreme problems. Part two consist of a visual analog scale (EQ-5D VAS); respondents assess their subjective health status on a 0 to 100 scale, where 0 is "the worst health you can image" and 100 "the best health you can imagine."
- Somatic health [ Time Frame: 6-, 12-, and 24-month follow-up ]Number of participants with somatic diagnoses according to ICD-10
- Withdrawal symptoms Opioids [ Time Frame: 6-, 12-, and 24-month follow-up ]Measured by the Subjective Opiate Withdrawal Scale (SOWS). The scale measures 16 common symptoms of opiate withdrawal. Symptoms are rated on a scale between 0 and 4, from "not at all" to "extremely." Higher scores indicating more withdrawal symptoms.
- Substitution treatment with opioids [ Time Frame: 6-, 12-, and 24-month follow-up ]Prescription registry data
- Withdrawal symptoms Benzodiazepines [ Time Frame: 6-, 12-, and 24-month follow-up ]The Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)
- Self-reported patient satisfaction with treatment [ Time Frame: 6-, 12-, and 24-month follow-up ]Self-report data using standard question in the National Patient Survey (Sweden). Items measures patients' experience and satisfaction with care. Items are rated on a scale between 1 ("Not at all") and 5 ("Totally agree"), with the possibility to answer "Not applicable".
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): NCT03713983
|Contact: Jeanette Westman, PhD, Co-PI||+46(0)8123 400 email@example.com|
|Contact: Sofia Lindmark, Master||+46(0)8123 400 firstname.lastname@example.org|
|Stockholm Centre for Dependency Disorders (www.beroendecentrum.se)||Recruiting|
|Contact: Sofia Lindmark, MS +46 08-123 458 44 email@example.com|
|Principal Investigator:||Johan Franck, Professor||Karolinska Institutet|