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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 : October 30, 2018
Sponsor:
Collaborator:
Public Health Agency of Sweden
Information provided by (Responsible Party):
Johan Franck, Karolinska Institutet

Brief Summary:
This study follows up patients who receive standard treatment for prescription narcotic drug use disorder, including opioids, benzodiazepines, and benzodiazepine-like drugs (z-drugs), at a specialized addiction service. The overall goal is to evaluate the proportion of patients who reduce or cease using prescription narcotics and the factors associated with treatment outcomes. No new treatments will be tested. Instead, the results will be used as the basis for a future randomized controlled trial to optimize treatment for narcotic drug use disorder.

Condition or disease Intervention/treatment
Drug Use Disorders Other: Observational study

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 81 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Other: Observational study
    Observational study


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Retention in treatment [ Time Frame: 6-, 12- and 24-month follow-up or at last visit ]
    Data collected from scheduled visit


Other Outcome Measures:
  1. 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

  2. Self-reported substance use [ Time Frame: 6-, 12-, and 24 month follow-up ]
    self-reported data using standard question in ASI

  3. Psychiatric comorbidity [ Time Frame: 6-, 12-, and 24-month follow-up ]
    Number of participants with psychiatric diagnoses according to ICD-10

  4. Personality traits [ Time Frame: 6-, 12-, and 24-month follow-ups ]
    SCID-2 Structured Clinical Interview for DSM-IV-Axis 2 Disorders, screening

  5. Insomnia [ Time Frame: 6-, 12-, and 24-month follow-up ]
    Insomnia Severity Index (ISI)

  6. 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).

  7. 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."

  8. Somatic health [ Time Frame: 6-, 12-, and 24-month follow-up ]
    Number of participants with somatic diagnoses according to ICD-10

  9. 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.

  10. Substitution treatment with opioids [ Time Frame: 6-, 12-, and 24-month follow-up ]
    Prescription registry data

  11. Withdrawal symptoms Benzodiazepines [ Time Frame: 6-, 12-, and 24-month follow-up ]
    The Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ)

  12. 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".



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients starting a new treatment period for prescription narcotic drug use disorder
Criteria

Inclusion Criteria:

  • Patients seeking treatment for prescription narcotic drug use disorder (ICD-10: F111, F112, F131, and F132)
  • ≥ 18 years
  • Willing to participate and who have provided written informed consent.

Exclusion Criteria:

  • Inability to understand spoken and written study information.
  • Having started tapering prior to the start of the study.

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): NCT03713983


Contacts
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Contact: Jeanette Westman, PhD, Co-PI +46(0)8123 400 00 jeanette.westman@ki.se
Contact: Sofia Lindmark, Master +46(0)8123 400 00 sofia.lindmark@sll.se

Locations
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Sweden
Stockholm Centre for Dependency Disorders (www.beroendecentrum.se) Recruiting
Stockholm, Sweden
Contact: Sofia Lindmark, MS    +46 08-123 458 44    sofia.lindmark@sll.se   
Sponsors and Collaborators
Johan Franck
Public Health Agency of Sweden
Investigators
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Principal Investigator: Johan Franck, Professor Karolinska Institutet

Additional Information:
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Responsible Party: Johan Franck, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03713983     History of Changes
Other Study ID Numbers: TAPE 2018
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

Keywords provided by Johan Franck, Karolinska Institutet:
behavior, addictive
addiction medicine
substance-related disorders
abuse, narcotic
addiction, narcotic
analgesics, narcotic
opioid-related disorders
benzodiazepines
prescription drugs

Additional relevant MeSH terms:
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Substance-Related Disorders
Disease
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents