NCT02604706

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

3.7 years

First QC Date

November 9, 2015

Last Update Submit

November 13, 2015

Conditions

Substance AbuseAnxietySleep

Outcome Measures

Primary Outcomes (1)

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

    5 weeks and 3 months

Secondary Outcomes (3)

  • 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

Study Arms (3)

NADA Acupuncture

EXPERIMENTAL

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

LP Acupuncture

EXPERIMENTAL

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

Relaxation

ACTIVE COMPARATOR

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

NADA AcupunctureDEVICE

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.

NADA Acupuncture
LP acupunctureDEVICE

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.

LP Acupuncture
RelaxationBEHAVIORAL

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.

Relaxation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ongoing patients status at the clinic.

You may not qualify if:

  • Nickel-allergy
  • Ear infection
  • Heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatric Research Centre

Örebro, Örebro County, 701 16, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 27451854DERIVED

MeSH Terms

Conditions

Substance-Related DisordersAnxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Rickard Ahlberg

    Örebro Läns Landsting

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical psychologist, doctoral student.

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 13, 2015

Study Start

October 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations

SE(1)