RCT of Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use and Use of Addiction Treatment Services. A Randomized Controlled Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 280
- Locations
- 1
- Primary Endpoint
- Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ongoing patients status at the clinic.
Exclusion Criteria
- •Nickel-allergy
- •Ear infection
- •Heart disease
Arms & Interventions
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.
Intervention: NADA Acupuncture (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. 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.
Intervention: LP acupuncture (Device)
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.
Intervention: Relaxation (Behavioral)
Outcomes
Primary Outcomes
Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).
Time Frame: 5 weeks and 3 months
Secondary Outcomes
- 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)
Investigators
Rickard Ahlberg
Clinical psychologist, doctoral student.
Örebro Läns Landsting