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Completed

NCT Number: NCT02604706

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

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.

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Key information

Conditions

Substance Abuse Anxiety Anxiety Disorders Chemically-Induced Disorders Mental Disorders Sleep Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Psychiatric Research Centre

Örebro, Örebro County, 701 16, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ongoing patients status at the clinic.

Exclusion criteria

  • Nickel-allergy
  • Ear infection
  • Heart disease

Treatment and study plan

NADA Acupuncture

Device

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

Device

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.

Relaxation

Behavioral

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.

Primary outcomes

  1. Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).

    Time frame: 5 weeks and 3 months

Secondary outcomes

  1. Change in self rated sleep quality measured with Insomnia Severity Index (ISI).

    Time frame: 5 weeks and 3 months

  2. Change in self rated drug use using The self-report Drug Use Disorders Identification Test (DUDIT).

    Time frame: 5 weeks and 3 months

  3. Change in self rated alcohol use using The self report Alcholol Disorders Identification Test (ADUIT).

    Time frame: 5 weeks ans 3 months

Sponsors and collaborators

Lead sponsor

Örebro Läns Landsting

Other Gov

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 13, 2015
Registry last updated
Nov 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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