AA on Drug Abusers by Nursing Students

Drug Abuse Clinical Trial

Official title:

Around the Turn: A Feasibility Cluster Randomized Controlled Trial of Using Auricular Acupressure to Abstain From Drug Abuse Through Training Nursing Students

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05877742
• Other study ID #: AA-drug abusers
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: May 20, 2024

Study information

• Verified date: May 2023
• Source: The Hong Kong Polytechnic University
• Contact: Ka Wai Katherine Lam
• Phone: 27666420
• Email: kw-katherine.lam[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 20, 2024
• Est. primary completion date: May 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Abuse
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Katherine Lam	Hong Kong	Hong Kong,China

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Eligibility rate	calculated by dividing the number of abusers who are eligible by the number who are screened.	at the 6-month follow-up
Primary	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
Primary	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
Primary	Attendance rate	calculated by dividing the number of abusers who complete the intervention by those who are randomized.	at the 6-month follow-up
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Self-reported abstinence	Self-reported drug abstinence at last 30 days.	at the 6-month follow-up
Secondary	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.	at the 6-month follow-up
Secondary	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.	at the 6-month follow-up
Secondary	Anxiety	Generalized anxiety disorder-7 will be used to measure the severity of self-reported anxiety.	at the 6-month follow-up
Secondary	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.	at the 6-month follow-up