Substance AbusePhase 2NCT02604706
Auricular Acupuncture in Substance Abuse: Effects on Anxiety, Sleep, Drug Use.
A Phase 2 study testing NADA Acupuncture, LP acupuncture and Relaxation in people with Substance Abuse and Anxiety, run by Örebro Läns Landsting at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Abuse, Anxiety, Sleep
- What is being tested?
- NADA Acupuncture, LP acupuncture and Relaxation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2010to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ongoing patients status at the clinic.
Who cannot join
- Nickel-allergy
- Ear infection
- Heart disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Substance Abuse, Anxiety, Sleep
- Being tested
- NADA Acupuncture, LP acupuncture, Relaxation
- Medical subject headings
- Substance-Related Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
RelaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).
Measured: 5 weeks and 3 months
Secondary outcomes (3)
Change in self rated sleep quality measured with Insomnia Severity Index (ISI).
Measured: 5 weeks and 3 months
Change in self rated drug use using The self-report Drug Use Disorders Identification Test (DUDIT).
Measured: 5 weeks and 3 months
Change in self rated alcohol use using The self report Alcholol Disorders Identification Test (ADUIT).
Measured: 5 weeks ans 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startOct 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro Läns Landsting
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rickard Ahlberg, Örebro Läns Landsting
- Investigators
- Rickard Ahlberg, Principal investigator, Örebro Läns Landsting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604706
- Sponsor's protocol ID
- 11
- Status last verified
- Nov 2015
- First submitted
- 9 Nov 2015
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02604706
- Acronym / sponsor ID
- 11
- Conditions
- Substance Abuse, Anxiety, Sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Örebro Läns LandstingOther government
- Study start
- Oct 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NADA Acupuncture | Experimental | Device: NADA AcupunctureNADA-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 | Experimental | Device: LP acupunctureThe 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 | Active comparator | Behavioral: RelaxationRelaxation 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ongoing patients status at the clinic.
Key exclusion criteria (3 listed)
- Nickel-allergy
- Ear infection
- Heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NADA AcupunctureNADA-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 acupunctureThe 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. | Device | LP Acupuncture |
| RelaxationRelaxation 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. | Behavioural | Relaxation |
Primary outcome
Change in self rated anxiety measured with Beck Anxiety Inventory (BAI).
Time frame: 5 weeks and 3 months
3 secondary outcomes
Change in self rated sleep quality measured with Insomnia Severity Index (ISI).
Time frame: 5 weeks and 3 months
Change in self rated drug use using The self-report Drug Use Disorders Identification Test (DUDIT).
Time frame: 5 weeks and 3 months
Change in self rated alcohol use using The self report Alcholol Disorders Identification Test (ADUIT).
Time frame: 5 weeks ans 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Derived from this study: PubMed 27451854Ahlberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rickard Ahlberg principal investigator
Örebro Läns Landsting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NADA Acupuncture, LP acupuncture and Relaxation in people with Substance Abuse and Anxiety, run by Örebro Läns Landsting at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self rated anxiety measured with Beck Anxiety Inventory (BAI). (time frame: 5 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.