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Predicting Dropout and Outcome From Neuropsychological Functions in SUD Patients

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ClinicalTrials.gov Identifier: NCT03220373
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Espen Walderhaug, Oslo University Hospital

Brief Summary:
The aim of this project is to gain a more specific understanding of how different cognitive profiles predict residential treatment drop-out, treatment retention and post-treatment outcome in a population with Substance Use Disorder.

Condition or disease
Substance Use Disorder (SUD)

Detailed Description:

This project collects the neuropsychological profile of residential SUD patients, in addition to treatment length, exit reason, hospital journal data and post-treatment clinical outcome data. The project aims to identify clinically relevant neurocognitive domains that predict treatment dropout and post-treatment clinical outcome. This will make it possible for future clinicians to focus their effort on neurocognitive functions most relevant for this particular patient group.

RESEARCH QUESTIONS:

  1. What neurocognitive domain (and sub-domain) are the strongest predictor of treatment drop-out and retention?
  2. What neurocognitive domain (and sub-domain) are the strongest predictor of post-treatment clinical outcome variables such as drug use, health and social integration.
  3. Will data on treatment length, age, gender, substance abuse history or psychiatric co-morbidity predict outcome independently, or in interaction with, the neuropsychological profile?

This longitudinal prospective cohort study aims for a continuous collection of neuropsychological data baseline and post-treatment follow-up data until 2030.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Predicting Early Treatment Termination (Dropout) and Post-treatment Clinical Outcome From Neuropsychological Functions in Abstinent Substance Use Dependent (SUD) Patients
Actual Study Start Date : March 7, 2017
Estimated Primary Completion Date : December 31, 2029
Estimated Study Completion Date : December 31, 2029



Primary Outcome Measures :
  1. Exit reason [ Time Frame: On average 3 months ]
    Reason for terminating residential SUD treatment (Treatment completed or Drop-out)

  2. Treatment retention [ Time Frame: On average 3 months ]
    Number of days in treatment


Secondary Outcome Measures :
  1. Substance use [ Time Frame: 1 year after neuropsychological assessment ]
    DUDIT (Drug Use Disorders Identification Test)

  2. Psychological distress [ Time Frame: 1 year after neuropsychological assessment ]
    SCL-10 (Symptom Checklist)

  3. Quality of Life [ Time Frame: 1 year after neuropsychological assessment ]
    QoL-5 (Quality of Life)

  4. ADHD symptoms [ Time Frame: 1 year after neuropsychological assessment ]
    ASRS (ADHD Self-Report Scale)

  5. Income [ Time Frame: 1 year after neuropsychological assessment ]
    Nature of income

  6. Housing [ Time Frame: 1 year after neuropsychological assessment ]
    Nature of present accommodation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Treatment seeking Substance Use Disorder (SUD) patients.
Criteria

Inclusion Criteria:

  • Substance Use Disorder (SUD) patients.
  • 18 years or older.
  • Qualified to consent to research participation.
  • Able to speak and write in Norwegian.

Exclusion Criteria:

  • Not qualified to consent to research participation.
  • Insufficient understanding of Norwegian.

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): NCT03220373


Contacts
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Contact: Espen Walderhaug, PhD +47 22029302 espwal@ous-hf.no
Contact: Arne Holen, PsyD +47 92230383 arhole@ous-hf.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0320
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Espen Walderhaug, PhD Oslo University Hospital

Additional Information:

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Responsible Party: Espen Walderhaug, Principal Investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03220373     History of Changes
Other Study ID Numbers: 2015/11288
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

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

Keywords provided by Espen Walderhaug, Oslo University Hospital:
Neuropsychology
Cognition
Drop-out
Follow-up

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders