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

Sponsor
Örebro Läns Landsting (Other)
Overall Status
Completed
CT.gov ID
NCT02604706
Collaborator
(none)
280
1
3
44
6.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: NADA Acupuncture
  • Device: LP acupuncture
  • Behavioral: Relaxation
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
RCT of Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use and Use of Addiction Treatment Services. A Randomized Controlled Study
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in self rated anxiety measured with Beck Anxiety Inventory (BAI). [5 weeks and 3 months]

Secondary Outcome Measures

  1. Change in self rated sleep quality measured with Insomnia Severity Index (ISI). [5 weeks and 3 months]

  2. Change in self rated drug use using The self-report Drug Use Disorders Identification Test (DUDIT). [5 weeks and 3 months]

  3. Change in self rated alcohol use using The self report Alcholol Disorders Identification Test (ADUIT). [5 weeks ans 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Ongoing patients status at the clinic.
Exclusion Criteria:
  • Nickel-allergy

  • Ear infection

  • Heart disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Psychiatric Research Centre Örebro Sweden 701 16

Sponsors and Collaborators

  • Örebro Läns Landsting

Investigators

  • Principal Investigator: Rickard Ahlberg, Örebro Läns Landsting

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rickard Ahlberg, Clinical psychologist, doctoral student., Örebro Läns Landsting
ClinicalTrials.gov Identifier:
NCT02604706
Other Study ID Numbers:
  • 11
First Posted:
Nov 13, 2015
Last Update Posted:
Nov 16, 2015
Last Verified:
Nov 1, 2015
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2015