Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use.

Anxiety Clinical Trial

Official title:

RCT of Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use and Use of Addiction Treatment Services. A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604706
• Other study ID #: 11
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2015
• Last updated: November 13, 2015
• Start date: October 2010
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: Örebro Läns Landsting
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Background. A common alternative treatment for substance abuse is ear acupuncture. The aim of the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety, sleep, drug use and addiction treatment utilization in adults with substance abuse. Method. Adults with substance abuse and psychiatric comorbidity were randomly assigned to either of two variants of auricular acupuncture - The National Acupuncture Detoxification Association protocol (NADA) or a local protocol (LP) - or relaxation training (controls). Primary outcomes were measured using the Beck Anxiety Inventory (BAI) and Insomnia Severity Index (ISI) with assessment before treatment and follow-ups after five weeks and three months. Secondary outcomes were drug use and addiction service utilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ongoing patients status at the clinic.

Exclusion Criteria:

• Nickel-allergy

• Ear infection

• Heart disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Sleep
• Substance Abuse
• Substance-Related Disorders

Intervention

Device:
• NADA Acupuncture
NADA-acupuncture was delivered in three phases: (1) one treatment each day during the first of a total of five weeks; (2) three treatments each week during the following two weeks; (3) two treatments each week during the two remaining weeks. each session consisted of approximately 40 minutes with acupuncture at five ear points called Sympathetic, Shen Men, Kidney, Liver and Lung, which are believed to be the best points for substance abuse patients. Acupuncture was administered to both ears using stainless steel needles. NADA-acupuncture were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.
• LP acupuncture
The LP-acupuncture was delivered in two phases: (1) three treatments each week during the two first weeks; (2) two treatments each week for two weeks. each session consisted of approximately 40 minutes with acupuncture at five ear points called Sympathetic, Shen Men, Kidney, Liver and Lung, which are believed to be the best points for substance abuse patients. Acupuncture was administered to both ears using stainless steel needles. LP-acupuncture were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.

Behavioral:
• Relaxation
Relaxation consisted of listening to soft music in a quiet room with dampened light and was delivered to match the amount and phases of the LP-acupuncture. Relaxation were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.

Locations

Country	Name	City	State
Sweden	Psychiatric Research Centre	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro Läns Landsting

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).		5 weeks and 3 months	No
Secondary	Change in self rated sleep quality measured with Insomnia Severity Index (ISI).		5 weeks and 3 months	No
Secondary	Change in self rated drug use using The self-report Drug Use Disorders Identification Test (DUDIT).		5 weeks and 3 months	No
Secondary	Change in self rated alcohol use using The self report Alcholol Disorders Identification Test (ADUIT).		5 weeks ans 3 months	No