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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03220373
Other study ID # 2015/11288
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date March 7, 2017
Est. completion date December 31, 2029

Study information

Verified date January 2024
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date December 31, 2029
Est. primary completion date December 31, 2029
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Locations

Country Name City State
Norway Oslo University Hospital Oslo

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Exit reason Reason for terminating residential SUD treatment (Treatment completed or Drop-out) On average 3 months
Primary Treatment retention Number of days in treatment On average 3 months
Secondary Substance use DUDIT (Drug Use Disorders Identification Test) 1 year after neuropsychological assessment
Secondary Psychological distress SCL-10 (Symptom Checklist) 1 year after neuropsychological assessment
Secondary Quality of Life QoL-5 (Quality of Life) 1 year after neuropsychological assessment
Secondary ADHD symptoms ASRS (ADHD Self-Report Scale) 1 year after neuropsychological assessment
Secondary Income Nature of income 1 year after neuropsychological assessment
Secondary Housing Nature of present accommodation 1 year after neuropsychological assessment
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