Drug AbuseNCT05877742
AA on Drug Abusers by Nursing Students
A study testing AA group in people with Drug Abuse, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Drug abuse is a serious public health issue. Despite the serious consequences of drug abuse, there are around 2000 new cases reported by drug abusers each year. There is growing evidence of the use of auricular acupressure (AA), a traditional Chinese medicine (TCM) treatment modality, in reducing withdrawal symptoms… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Abuse
- What is being tested?
- AA group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Mar 2023to 20 Jun 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or above
- Have reported to abuse drugs within the past 30 days
- Can communicate in Cantonese and read Chinese
Who cannot join
- Unstable mental conditions that are not suitable for the intervention
- Receiving acupuncture or acupressure treatment currently or in the previous 30 days
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Katherine Lam
Hong Kong, 0000
Katherine Lam, Phd
About this study
Official title: Around the Turn: A Feasibility Cluster Randomized Controlled Trial of Using Auricular Acupressure to Abstain From Drug Abuse Through Training Nursing Students
Drug abuse is a serious public health issue. Despite the serious consequences of drug abuse, there are around 2000 new cases reported by drug abusers each year. There is growing evidence of the use of auricular acupressure (AA), a traditional Chinese medicine (TCM) treatment modality, in reducing withdrawal symptoms among drug abusers. This study aims to investigate the feasibility and effectiveness of training nursing students to deliver brief education on AA on drug abusers.
Read the detailed description
A 2-arm feasibility cluster RCT will be conducted in the 80 drug abusers from 7 substance abuse clinics in Hong Kong Hospital Authority following the CONSORT statement. The intervention group will receive AA intervention individually from trained nursing students. The control group will individually receive a 5-minute seminar delivered by a research assistant.
- Conditions
- Drug Abuse
- Being tested
- AA group, Control group
- Keywords
- Auricular Acupressure, Nursing Students
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AA groupOther
Participants will individually receive a 5-minute AA education delivered verbally at his/her respective clinic by a trained nursing student interventionist in addition to the usual scheduled follow-ups and activities at clinics.
Control groupOther
To mimic the time and attention spent, the control group will individually receive a 5-minute seminar delivered by an RA.
| Study group | Role | What they receive |
|---|---|---|
| AA group | Experimental | AA for drug abusers. Receives: Other: AA group |
| Control group | Placebo comparator | Routine seminar for drug abusers. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
calculated as the number of abusers screened at participated clinics divided by number of abusers at participated clinics during the recruitment period.
Measured: at the 6-month follow-up
Eligibility rate
calculated by dividing the number of abusers who are eligible by the number who are screened.
Measured: at the 6-month follow-up
Consent rate
calculated by dividing the number of abusers who consent to join the study by the number who are eligible.
Measured: at the 6-month follow-up
Randomization rate
calculated by dividing the number of abusers who are randomized into intervention and control groups by those who provide consent.
Measured: at the 6-month follow-up
Attendance rate
calculated by dividing the number of abusers who complete the intervention by those who are randomized.
Measured: at the 6-month follow-up
Retention rate
: calculated by dividing the number of abusers who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.
Measured: at the 6-month follow-up
Adherence to intervention protocol
calculated by dividing the number of abusers who follow the intervention protocol by those who are randomized.
Measured: at the 6-month follow-up
Complete rate
calculated by dividing the number of abusers who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.
Measured: at the 6-month follow-up
Missing data
calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Measured: at the 6-month follow-up
Adverse events
defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study.
Measured: at the 6-month follow-up
Secondary outcomes (5)
Self-reported abstinence
Self-reported drug abstinence at last 30 days.
Measured: at the 6-month follow-up
Abstinence with urine testing
. Those who report no drug abuse within the past 30 days at the 6-month follow-up will be further invited for urine testing.
Measured: at the 6-month follow-up
Self-reported levels of craving
The Chinese version of the 3-item craving scale will be used to measure abusers' self-reported levels of craving.
Measured: at the 6-month follow-up
Anxiety
Generalized anxiety disorder-7 will be used to measure the severity of self-reported anxiety.
Measured: at the 6-month follow-up
Quality of life measures by short-Form Six-Dimension
Short-Form Six-Dimension will be used to assess abusers' quality of life.It contains six dimensions of health. The Chinese version is well validated in Hong Kong.
Measured: at the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start20 Mar 2023
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Katherine Lam, The Hong Kong Polytechnic University
- Investigators
- Ka Wai Katherine Lam, Principal investigator, School of Nursing, Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05877742
- Sponsor's protocol ID
- AA-drug abusers
- Status last verified
- May 2024
- First submitted
- 16 May 2023
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Around the Turn: A Feasibility Cluster Randomized Controlled Trial of Using Auricular Acupressure to Abstain From Drug Abuse Through Training Nursing Students
- ClinicalTrials.gov ID
- NCT05877742
- Acronym / sponsor ID
- AA-drug abusers
- Conditions
- Drug Abuse
- Keywords
- Auricular Acupressure, Nursing Students
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 26 May 2023 (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.
Drug abuse is a serious public health issue. Despite the serious consequences of drug abuse, there are around 2000 new cases reported by drug abusers each year. There is growing evidence of the use of auricular acupressure (AA), a traditional Chinese medicine (TCM) treatment modality, in reducing withdrawal symptoms among drug abusers. This study aims to investigate the feasibility and effectiveness of training nursing students to deliver brief education on AA on drug abusers.
Detailed description
A 2-arm feasibility cluster RCT will be conducted in the 80 drug abusers from 7 substance abuse clinics in Hong Kong Hospital Authority following the CONSORT statement. The intervention group will receive AA intervention individually from trained nursing students. The control group will individually receive a 5-minute seminar delivered by a research assistant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AA group | Experimental | Other: AA groupAA for drug abusers. |
| Control group | Placebo comparator | Other: Control groupRoutine seminar for drug abusers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 or above
- Have reported to abuse drugs within the past 30 days
- Can communicate in Cantonese and read Chinese
Key exclusion criteria (2 listed)
- Unstable mental conditions that are not suitable for the intervention
- Receiving acupuncture or acupressure treatment currently or in the previous 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AA groupParticipants will individually receive a 5-minute AA education delivered verbally at his/her respective clinic by a trained nursing student interventionist in addition to the usual scheduled follow-ups and activities at clinics. | Other | AA group |
| Control groupTo mimic the time and attention spent, the control group will individually receive a 5-minute seminar delivered by an RA. | Other | Control group |
Primary outcome
Screening rate
Time frame: at the 6-month follow-up
calculated as the number of abusers screened at participated clinics divided by number of abusers at participated clinics during the recruitment period.
Eligibility rate
Time frame: at the 6-month follow-up
calculated by dividing the number of abusers who are eligible by the number who are screened.
Consent rate
Time frame: at the 6-month follow-up
calculated by dividing the number of abusers who consent to join the study by the number who are eligible.
Randomization rate
Time frame: at the 6-month follow-up
calculated by dividing the number of abusers who are randomized into intervention and control groups by those who provide consent.
Attendance rate
Time frame: at the 6-month follow-up
calculated by dividing the number of abusers who complete the intervention by those who are randomized.
Retention rate
Time frame: at the 6-month follow-up
: calculated by dividing the number of abusers who remain in the study by those who are randomized. Retention rates for the intervention and control groups will be calculated at each follow-up.
Adherence to intervention protocol
Time frame: at the 6-month follow-up
calculated by dividing the number of abusers who follow the intervention protocol by those who are randomized.
Complete rate
Time frame: at the 6-month follow-up
calculated by dividing the number of abusers who returned questionnaires by the number of questionnaires distributed. This will be calculated by groups at baseline and each follow-up.
Missing data
Time frame: at the 6-month follow-up
calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Adverse events
Time frame: at the 6-month follow-up
defined as unfavorable and unintended events that are not present at baseline, or appear to have worsened during the study.
5 secondary outcomes
Self-reported abstinence
Time frame: at the 6-month follow-up
Abstinence with urine testing
Time frame: at the 6-month follow-up
Self-reported levels of craving
Time frame: at the 6-month follow-up
Anxiety
Time frame: at the 6-month follow-up
Quality of life measures by short-Form Six-Dimension
Time frame: at the 6-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
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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.
Ka Wai Katherine Lam principal investigator
School of Nursing, Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AA group in people with Drug Abuse, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Apr 2025. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Wai Katherine Lam (27666420, kw-katherine.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: at the 6-month follow-up). The study lists 10 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 20 Apr 2025.