AA on Drug Abusers by Nursing Students

April 16, 2025 updated by: Dr Katherine Lam, The Hong Kong Polytechnic University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 0000
        • Recruiting
        • Katherine Lam
        • Contact:
          • Katherine Lam, Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 or above
  • Have reported to abuse drugs within the past 30 days
  • Can communicate in Cantonese and read Chinese

Exclusion Criteria:

  • Unstable mental conditions that are not suitable for the intervention
  • Receiving acupuncture or acupressure treatment currently or in the previous 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AA group
AA for drug abusers.
Other: AA group
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.
Placebo Comparator: Control group
Routine seminar for drug abusers.
Other: Control group
To mimic the time and attention spent, the control group will individually receive a 5-minute seminar delivered by an RA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the 6-month follow-up
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.
at the 6-month follow-up
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.
at the 6-month follow-up
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.
at the 6-month follow-up
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.
at the 6-month follow-up
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.
at the 6-month 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.
at the 6-month follow-up
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.
at the 6-month 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.
at the 6-month follow-up
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.
at the 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported abstinence
Time Frame: at the 6-month follow-up
Self-reported drug abstinence at last 30 days.
at the 6-month follow-up
Abstinence with urine testing
Time Frame: at the 6-month follow-up
. Those who report no drug abuse within the past 30 days at the 6-month follow-up will be further invited for urine testing.
at the 6-month follow-up
Self-reported levels of craving
Time Frame: at the 6-month follow-up
The Chinese version of the 3-item craving scale will be used to measure abusers' self-reported levels of craving.
at the 6-month follow-up
Anxiety
Time Frame: at the 6-month follow-up
Generalized anxiety disorder-7 will be used to measure the severity of self-reported anxiety.
at the 6-month follow-up
Quality of life measures by short-Form Six-Dimension
Time Frame: at the 6-month follow-up
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.
at the 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Ka Wai Katherine Lam, School of Nursing, Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Estimated)

June 20, 2025

Study Completion (Estimated)

June 20, 2025

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

May 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AA-drug abusers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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