CClinicalTrials.gg
CompletedNCT02604706Updated Nov 16, 2015

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

A Phase 2 interventional study of NADA Acupuncture and LP acupuncture in Substance Abuse, Anxiety and Sleep, sponsored by Örebro Läns Landsting. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-11-16.

Sponsored by Örebro Läns Landsting · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
280
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Substance Abuse
  • Anxiety
  • Sleep
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In context

Substance-Related Disorders

2,126 studies on the registry are indexed under Substance-Related Disorders; 395 are open to participants now.

This study's enrollment of 280 is above the median of 109 across 1,728 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Örebro Läns Landsting is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ongoing patients status at the clinic.

Exclusion criteria

Exclusion Criteria:

  • Nickel-allergy
  • Ear infection
  • Heart disease
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DeviceNADA 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.

  • DeviceLP 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.

  • BehavioralRelaxation

    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.

06

What researchers measure

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

07

Study locations

1 site
  • Psychiatric Research Centre
    Örebro, 701 16, Sweden
08

References and documents

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. PubMed 27451854 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02604706
Lead sponsor
Örebro Läns Landsting
Responsible party
Rickard Ahlberg (Clinical psychologist, doctoral student., Örebro Läns Landsting) — Principal investigator
First posted
Nov 13, 2015
Start date
Oct 2010
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Nov 16, 2015

Study contacts

Rickard Ahlberg
principal investigator · Örebro Läns Landsting

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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