NCT05877742

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
Last Updated

April 20, 2025

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

May 16, 2023

Last Update Submit

April 16, 2025

Conditions

Keywords

Auricular AcupressureNursing Students

Outcome Measures

Primary Outcomes (10)

  • Screening rate

    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

    calculated by dividing the number of abusers who are eligible by the number who are screened.

    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.

    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.

    at the 6-month follow-up

  • Attendance rate

    calculated by dividing the number of abusers who complete the intervention by those who are randomized.

    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.

    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.

    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.

    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.

    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.

    at the 6-month follow-up

Secondary Outcomes (5)

  • Self-reported abstinence

    at the 6-month follow-up

  • Abstinence with urine testing

    at the 6-month follow-up

  • Self-reported levels of craving

    at the 6-month follow-up

  • Anxiety

    at the 6-month follow-up

  • Quality of life measures by short-Form Six-Dimension

    at the 6-month follow-up

Study Arms (2)

AA group

EXPERIMENTAL

AA for drug abusers.

Other: AA group

Control group

PLACEBO COMPARATOR

Routine seminar for drug abusers.

Other: Control group

Interventions

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.

AA group

To mimic the time and attention spent, the control group will individually receive a 5-minute seminar delivered by an RA.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katherine Lam

Hong Kong, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ka Wai Katherine Lam

    School of Nursing, Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

May 16, 2023

First Posted

May 26, 2023

Study Start

March 20, 2023

Primary Completion

June 20, 2025

Study Completion

June 20, 2025

Last Updated

April 20, 2025

Record last verified: 2024-05

Locations