- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03220373
Predicting Dropout and Outcome From Neuropsychological Functions in SUD Patients
Predicting Early Treatment Termination (Dropout) and Post-treatment Clinical Outcome From Neuropsychological Functions in Abstinent Substance Use Dependent (SUD) Patients
Study Overview
Status
Conditions
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:
- What neurocognitive domain (and sub-domain) are the strongest predictor of treatment drop-out and retention?
- What neurocognitive domain (and sub-domain) are the strongest predictor of post-treatment clinical outcome variables such as drug use, health and social integration.
- 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
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Oslo, Norway, 0320
- Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exit reason
Time Frame: On average 3 months
|
Reason for terminating residential SUD treatment (Treatment completed or Drop-out)
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On average 3 months
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Treatment retention
Time Frame: On average 3 months
|
Number of days in treatment
|
On average 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Substance use
Time Frame: 1 year after neuropsychological assessment
|
DUDIT (Drug Use Disorders Identification Test)
|
1 year after neuropsychological assessment
|
Psychological distress
Time Frame: 1 year after neuropsychological assessment
|
SCL-10 (Symptom Checklist)
|
1 year after neuropsychological assessment
|
Quality of Life
Time Frame: 1 year after neuropsychological assessment
|
QoL-5 (Quality of Life)
|
1 year after neuropsychological assessment
|
ADHD symptoms
Time Frame: 1 year after neuropsychological assessment
|
ASRS (ADHD Self-Report Scale)
|
1 year after neuropsychological assessment
|
Income
Time Frame: 1 year after neuropsychological assessment
|
Nature of income
|
1 year after neuropsychological assessment
|
Housing
Time Frame: 1 year after neuropsychological assessment
|
Nature of present accommodation
|
1 year after neuropsychological assessment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Espen Walderhaug, PhD, Oslo University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/11288
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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