- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07395453
Assessments of Obsessive-compulsive Symptoms in Patients With Substances Use Disorder
Assessments of Obsessive-compulsive Symptoms in Patients With Substances Use Disorder and Its Correlates
Study Overview
Status
Detailed Description
Substance use disorders and obsessive-compulsive disorder are chronic, relapsing conditions that share underlying neurobiological mechanisms related to compulsivity and have substantial impact on functioning and quality of life. Clinical experience and prior research suggest that obsessive-compulsive symptoms may be under-recognized among individuals with substance use disorders, where they can worsen psychiatric comorbidity, complicate treatment, and impair recovery.
The current study will recruit 102 adults aged 18-50 years, including 51 patients with a diagnosed substance use disorder (single or polysubstance) from the inpatient and outpatient addiction management unit at the Neuropsychiatry Department, Assiut University Hospital, and 51 control participants without substance use disorder drawn from relatives, friends, and hospital workers. All participants must be in a non-intoxicated, non-withdrawal state and able to provide informed consent; individuals with severe psychiatric disorders (such as schizophrenia, bipolar disorder, major depressive disorder with severe features, or anorexia nervosa), severe medical illness, or marked cognitive impairment will be excluded.
Data collection will include a structured sociodemographic and clinical sheet, brief psychiatric interview, and administration of validated instruments such as the Yale-Brown Obsessive-Compulsive Scale, Obsessive Compulsive Drug Use Scale, Symptom Checklist-90-R, Montreal Cognitive Assessment, and Hamilton scales for anxiety and depression, along with urine analysis for substances. The primary objective is to assess the correlation between obsessive-compulsive symptoms in patients with substance use disorder and both symptom severity and quality of life, while secondary objectives address compulsive aspects of addiction, craving in patients with obsessive-compulsive symptoms, and potential implications for management strategies.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
--Adults aged 18-50 years.
- Willing and able to provide informed consent and participate in the study assessments.
- For the case group: patients with a diagnosed substance use disorder (single or polysubstance) attending the inpatient or outpatient addiction management unit at the Neuropsychiatry Department, Assiut University Hospital.
- For the control group: relatives, friends, or hospital workers without substance use disorder, recruited through invitation or advertisement.
Exclusion Criteria:
- Severe psychiatric comorbidities such as schizophrenia, major depressive disorder, bipolar disorder, or anorexia nervosa.
- Current intoxication or acute withdrawal state from substances.
- Severe medical conditions including end-stage renal disease, metastatic cancer, severe heart failure, or chronic obstructive pulmonary disease.
- Severe cognitive impairment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Substance Use Disorder Patients
Adults aged 18-50 years with a diagnosed substance use disorder (single or polysubstance) attending the inpatient or outpatient addiction management unit at Assiut University Hospital, assessed for obsessive-compulsive symptoms, psychiatric comorbidities, cognition, and quality of life using standardized scales and urine toxicology.
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Healthy Control Group
Adults aged 18-50 years without substance use disorder, recruited from relatives, friends, or hospital workers, matched on sociodemographic characteristics where feasible, and assessed with the same clinical and psychometric battery to compare obsessive-compulsive symptoms and related outcomes with the patient group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of Obsessive-Compulsive Symptoms in Patients with Substance Use Disorder Measured by Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Total Score
Time Frame: Baseline (study enrollment during recovery stage defined as non-intoxication and non-withdrawal); single assessment
|
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score assessing severity of obsessive-compulsive symptoms in patients with substance use disorder.
Scale ranges from 0 to 40 points, where higher scores indicate greater severity, assessed once at study enrollment during recovery stage defined as non-intoxication and non-withdrawal.
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Baseline (study enrollment during recovery stage defined as non-intoxication and non-withdrawal); single assessment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- OCD in substances use disorder
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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