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

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Anxiety; Substance Abuse
• Intervention / Treatment: Device: NADA Acupuncture; Device: LP acupuncture; Behavioral: Relaxation

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 701 16
    • Psychiatric Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ongoing patients status at the clinic.

Exclusion Criteria:

• Nickel-allergy
• Ear infection
• Heart disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: 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. BC-acupuncture were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.	Device: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).	5 weeks and 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in self rated sleep quality measured with Insomnia Severity Index (ISI).	5 weeks and 3 months
Change in self rated drug use using The self-report Drug Use Disorders Identification Test (DUDIT).	5 weeks and 3 months
Change in self rated alcohol use using The self report Alcholol Disorders Identification Test (ADUIT).	5 weeks ans 3 months

Collaborators and Investigators

• Sponsor: Örebro Läns Landsting
• Investigators: Principal Investigator: Rickard Ahlberg, Orebro lans landsting

Publications and helpful links

General Publications

• Ahlberg R, Skarberg K, Brus O, Kjellin L. Auricular acupuncture for substance use: a randomized controlled trial of effects on anxiety, sleep, drug use and use of addiction treatment services. Subst Abuse Treat Prev Policy. 2016 Jul 25;11(1):24. doi: 10.1186/s13011-016-0068-z.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 9, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Estimate): November 16, 2015
• Last Update Submitted That Met QC Criteria: November 13, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Anxiety Disorders
• Other Study ID Numbers: 11