Drug Abuse Clinical Trial
— WePN-DAOfficial title:
Westlake Personalized Nutrition and Health Cohort for Drug Addicts
Verified date | October 2020 |
Source | Westlake University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective cohort study of drug addicts confined in Zhejiang rehabilitation centers. The primary aim of this study is to investigate the association between diet and health status among drug addicts. The second aim is to characterize the continuous blood glucose response to dietary intakes over 2 weeks. The third aim is to describe the dynamic changes of gut microbiota at three time points in drug addicts during compulsory detoxification and to evaluate the association between gut microbiota, diet and addiction severity.
Status | Completed |
Enrollment | 228 |
Est. completion date | January 20, 2021 |
Est. primary completion date | January 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Drug addicts aged between 18 yrs and 65yrs. - Drug addicts lived in Zhejiang drug rehabilitation centers. - Drug addicts who have stayed in drug rehabilitation center for no more than 6 months. Exclusion Criteria: - Drug addicts diagnosed with cancer or other serious physical and mental disorders. |
Country | Name | City | State |
---|---|---|---|
China | Zhejiang Drug Rehabilitation Administration | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Westlake University | Zhejiang Drug Rehabilitation Administration |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Continuous blood glucose profile over 2 weeks | Glucose levels were measured using continuous glucose monitoring over 2 week | Two weeks after enrollment | |
Primary | The dynamic change of gut microbiota within one year | Fecal microbiota was analyzed using16S rRNA gene sequencing technique | One year after enrollment; includes three sampling time points: baseline, 6 months after enrollment and 12 months after enrollment. | |
Secondary | Drug craving intensity | This was evaluated by Obsessive Compulsive Drug Use Scale (OCDUS). This scale had 13 items, each with a 5-point Likert-response (1, 2, 3, 4 and 5). Items 6 and 13 were reverse-scored. The total score ranges from 13 to 65 and a higher value represent a higher intensity of drug craving. | Baseline; 6 months after enrollment; 12 months after enrollment | |
Secondary | The change of BMI | BMI in kg/m^2 | Baseline; 6 months after enrollment; 12 months after enrollment | |
Secondary | Nutritional status | Nutritional status was measured by mini nutritional assessment (MNA) screening test. | Baseline; 6 months after enrollment; 12 months after enrollment | |
Secondary | The degree of depression | This was evaluated by Beck Depression Inventory-II (BDI-II). Scores in every item of the BDI-II were between 0 and 3. The total score ranges from 0 to 63. | Baseline; 6 months after enrollment; 12 months after enrollment | |
Secondary | The degree of anxiety | This was evaluated by Hamilton Anxiety Scale (HAMA). Scores in every item of the HAMA were between 0 and 4. The total score ranges from 0 to 56. | Baseline; 6 months after enrollment; 12 months after enrollment | |
Secondary | Body composition | Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis. | Baseline; 6 months after enrollment; 12 months after enrollment |
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