Drug AddictionWePN-DANCT04105621
Westlake Personalized Nutrition and Health Cohort for Drug Addicts
An observational study of Drug Addiction and Undernutrition, run by Westlake University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Drug Addiction, Undernutrition, Drug Abuse
- How many people
- 228 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2019to 20 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Drug addicts confined in Zhejiang drug rehabilitation centers will be recruited.
Who may be able to join
- 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.
Who cannot join
- Drug addicts diagnosed with cancer or other serious physical and mental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhejiang Drug Rehabilitation Administration
Hangzhou, Zhejiang, 310008
About this study
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.
Read the detailed description
Over recent decades, there is a growing trend of drug addiction in China that poses great public health challenges. Drug abuse can lead to many health related problems such as malnutrition and mental disorders along with reduced quality of life. Dietary intervention plays a pivotal role in disease prevention and drug rehabilitation for drug addicts, but the associations between dietary intake and health related outcomes among drug addicts remain unclear.
In addition, the relationship between the human gut microbiota and its response to addictive drugs as a newly arisen subject is given wide attention in recent years. However, the underlying mechanism requires further investigation. The dynamic changes of gut microbiota among drug addicts during compulsory drug rehabilitation period are in vague.
Under the same diet exposure, different drug addicts may have different blood glucose responses as well as gut microbiota profiles. Therefore, in order to examine the association between diet, gut microbiota and drug addiction, our study design will include three components: (1) the measurement of dietary intake using FFQ while the menu offered by drug rehabilitation center and food diary; (2) the measurements of blood glucose over 2 weeks using continuous glucose monitors; and (3) the measurements of gut microbiota at three time points using 16s rRNA sequencing techniques.
- Conditions
- Drug Addiction, Undernutrition, Drug Abuse
- Keywords
- Personalized nutrition, Drug addicts, Gut microbiota
- Medical subject headings
- Substance-Related Disorders, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Drug addicts | This group included drug addicts lived in drug rehablitation center. | |
| Healthy population | We recruited the healthy participants from the Westlake N-of-1 Trials for Macronutrient Intake (NCT04125602) as healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous blood glucose profile over 2 weeks
Glucose levels were measured using continuous glucose monitoring over 2 week
Measured: Two weeks after enrollment
The dynamic change of gut microbiota within one year
Fecal microbiota was analyzed using16S rRNA gene sequencing technique
Measured: One year after enrollment; includes three sampling time points: baseline, 6 months after enrollment and 12 months after enrollment.
Secondary outcomes (6)
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.
Measured: Baseline; 6 months after enrollment; 12 months after enrollment
The change of BMI
BMI in kg/m^2
Measured: Baseline; 6 months after enrollment; 12 months after enrollment
Nutritional status
Nutritional status was measured by mini nutritional assessment (MNA) screening test.
Measured: Baseline; 6 months after enrollment; 12 months after enrollment
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.
Measured: Baseline; 6 months after enrollment; 12 months after enrollment
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.
Measured: Baseline; 6 months after enrollment; 12 months after enrollment
Body composition
Body composition (fat mass, lean mass in kg ) are assessed by bioelectrical impedance analysis.
Measured: Baseline; 6 months after enrollment; 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start28 Oct 2019
- Primary completion20 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Drug Rehabilitation Administration
- Responsible party
- Sponsor
- Investigators
- Ju-Sheng Zheng, PhD, Principal investigator, Westlake University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105621
- Sponsor's protocol ID
- 20190812ZJS0009
- Acronym
- WePN-DA
- Status last verified
- Oct 2020
- First submitted
- 1 Sep 2019
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Westlake Personalized Nutrition and Health Cohort for Drug Addicts
- ClinicalTrials.gov ID
- NCT04105621
- Acronym / sponsor ID
- WePN-DA / 20190812ZJS0009
- Conditions
- Drug Addiction, Undernutrition, Drug Abuse
- Keywords
- Personalized nutrition, Drug addicts, Gut microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Drug Rehabilitation Administration
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 20 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over recent decades, there is a growing trend of drug addiction in China that poses great public health challenges. Drug abuse can lead to many health related problems such as malnutrition and mental disorders along with reduced quality of life. Dietary intervention plays a pivotal role in disease prevention and drug rehabilitation for drug addicts, but the associations between dietary intake and health related outcomes among drug addicts remain unclear.
In addition, the relationship between the human gut microbiota and its response to addictive drugs as a newly arisen subject is given wide attention in recent years. However, the underlying mechanism requires further investigation. The dynamic changes of gut microbiota among drug addicts during compulsory drug rehabilitation period are in vague.
Under the same diet exposure, different drug addicts may have different blood glucose responses as well as gut microbiota profiles. Therefore, in order to examine the association between diet, gut microbiota and drug addiction, our study design will include three components: (1) the measurement of dietary intake using FFQ while the menu offered by drug rehabilitation center and food diary; (2) the measurements of blood glucose over 2 weeks using continuous glucose monitors; and (3) the measurements of gut microbiota at three time points using 16s rRNA sequencing techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug addicts | – | –This group included drug addicts lived in drug rehablitation center. |
| Healthy population | – | –We recruited the healthy participants from the Westlake N-of-1 Trials for Macronutrient Intake (NCT04125602) as healthy control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Drug addicts confined in Zhejiang drug rehabilitation centers will be recruited.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Drug addicts diagnosed with cancer or other serious physical and mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Continuous blood glucose profile over 2 weeks
Time frame: Two weeks after enrollment
Glucose levels were measured using continuous glucose monitoring over 2 week
The dynamic change of gut microbiota within one year
Time frame: One year after enrollment; includes three sampling time points: baseline, 6 months after enrollment and 12 months after enrollment.
Fecal microbiota was analyzed using16S rRNA gene sequencing technique
6 secondary outcomes
Drug craving intensity
Time frame: Baseline; 6 months after enrollment; 12 months after enrollment
The change of BMI
Time frame: Baseline; 6 months after enrollment; 12 months after enrollment
Nutritional status
Time frame: Baseline; 6 months after enrollment; 12 months after enrollment
The degree of depression
Time frame: Baseline; 6 months after enrollment; 12 months after enrollment
The degree of anxiety
Time frame: Baseline; 6 months after enrollment; 12 months after enrollment
Body composition
Time frame: Baseline; 6 months after enrollment; 12 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ju-Sheng Zheng, PhD principal investigator
Westlake University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Addiction and Undernutrition, run by Westlake University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous blood glucose profile over 2 weeks (time frame: Two weeks after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.