Back to resultsAuricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use.
Primary Purpose
Substance Abuse, Anxiety, Sleep
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
NADA Acupuncture
LP acupuncture
Relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Substance Abuse
Eligibility Criteria
Inclusion Criteria:
- Ongoing patients status at the clinic.
Exclusion Criteria:
- Nickel-allergy
- Ear infection
- Heart disease
Sites / Locations
- Psychiatric Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
NADA Acupuncture
LP Acupuncture
Relaxation
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).
Secondary Outcome Measures
Change in self rated sleep quality measured with Insomnia Severity Index (ISI).
Change in self rated drug use using The self-report Drug Use Disorders Identification Test (DUDIT).
Change in self rated alcohol use using The self report Alcholol Disorders Identification Test (ADUIT).
Full Information
NCT ID
NCT02604706
First Posted
November 9, 2015
Last Updated
November 13, 2015
Sponsor
Örebro Läns Landsting
1. Study Identification
Unique Protocol Identification Number
NCT02604706
Brief Title
Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use.
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 Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro Läns Landsting
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Anxiety, Sleep
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NADA Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
LP Acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
Relaxation
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
NADA Acupuncture
Intervention Description
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 Type
Device
Intervention Name(s)
LP acupuncture
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation
Intervention Description
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 Outcome Measure Information:
Title
Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).
Time Frame
5 weeks and 3 months
Secondary Outcome Measure Information:
Title
Change in self rated sleep quality measured with Insomnia Severity Index (ISI).
Time Frame
5 weeks and 3 months
Title
Change in self rated drug use using The self-report Drug Use Disorders Identification Test (DUDIT).
Time Frame
5 weeks and 3 months
Title
Change in self rated alcohol use using The self report Alcholol Disorders Identification Test (ADUIT).
Time Frame
5 weeks ans 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ongoing patients status at the clinic.
Exclusion Criteria:
Nickel-allergy
Ear infection
Heart disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rickard Ahlberg
Organizational Affiliation
Örebro Läns Landsting
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Research Centre
City
Örebro
ZIP/Postal Code
701 16
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
27451854
Citation
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.
Results Reference
derived
Learn more about this trial
Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use.
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