Opioid-use DisorderNCT02033746
Opiate Craving Reduction Study Using Post-detox Patients on Suboxone and Use of TEAS as Adjunctive Treatment
A study testing Han's Acupoint Nerve Stimulator in people with Opioid-use Disorder, run by Mclean Hospital at 1 site in United States.
Trial summary
Pilot study of 12 outpatients in early recovery from illicit drug use,post-detox and on buprenorphine-naloxone maintenance will be offered 12 TEAS adjunct treatments over 6 weeks(X2/week) to ascertain if they experience any improvement in mood,sleep,overall quality of life and decrease drug cravings ultimately while… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Opioid-use Disorder
- What is being tested?
- Han's Acupoint Nerve Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2017
- Phase
- Interventional
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-59 years old
- early recovery(0-3months of abstinence
- not currently detoxing
- maintained on buprenorphine-naloxone under the care of qualified MD
- proficient in the English language
Who cannot join
- having acute,psychiatric symptoms which would pose safety concerns,or an adherence to treatment barrier(active suicidality/psychosis/mania)
- severe cognitive disorders*not competent to give informed consent
- active cardiac disease or EKG abnormalities or with cardiac pacemaker
- currently detoxing from alcohol or illicit drugs
- inability or non-intention to attend all treatment sessions*history of seizures*pregnancy or breast feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Crossover Study Using Transdermal Electroacupuncture as Adjunctive Treatment to Reduce Opiate Cravings in Post-Detox Outpatients Receiving Buprenorphine-Naloxone
Pilot study of 12 outpatients in early recovery from illicit drug use,post-detox and on buprenorphine-naloxone maintenance will be offered 12 TEAS adjunct treatments over 6 weeks(X2/week) to ascertain if they experience any improvement in mood,sleep,overall quality of life and decrease drug cravings ultimately while facing everyday life stressors.
Read the detailed description
- this crossover study will involve participants who will be randomized into two treatment groups,A\&B. TEAS treatments will be given for 30 minutes,X2/week,for 6 weeks(12total sessions). Group A will receive 2 weeks(4 sessions) of active treatment followed by 4 weeks of sham treatment(8 sessions). Group B will receive 2 weeks(4 sessions) of sham treatment,2 weeks (4 sessions)of real treatment,and finally 2 weeks (4 sessions) of sham treatment.
- parameters to be measured include vital signs and questionnaires weeks 1,3,5,6 to assess self-reported past 14-day substance use,alcohol and drug craving,withdrawal symptoms,sleep,mood,pain and overall quality of life.
- goals include better lives for post-detox opiate addicts as they incorporate this treatment into their lives,saving themselves and loved ones more horror,and their communities resources.
- Conditions
- Opioid-use Disorder
- Being tested
- Han's Acupoint Nerve Stimulator
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Han's Acupoint Nerve StimulatorDevice
frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Electroacupuncture - Arm A | Experimental | week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator while receiving concurrent buprenorphine-naloxone as prescribed Receives: Device: Han's Acupoint Nerve Stimulator |
| Transdermal Electroacupuncture - Arm B | Experimental | week 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator treatment while receiving concurrent buprenorphine-naloxone as prescribed Receives: Device: Han's Acupoint Nerve Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions
Measured: 6 weeks
Secondary outcomes (4)
Number of participants who experience improvement in mood
Mood measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16) questionnaire.
Measured: 6 weeks
Number of participants who experience improvement in sleep
Sleep patterns measure by self report through the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Measured: 6 weeks
Number of participants who experience improvement in Quality-of-Life
Quality-of-Life measured by self-report through Short Form (SF)-36 questionnaire
Measured: 6 weeks
Number of participants who report fewer cravings for drugs and alcohol
Cravings for drugs and alcohol measure by self-report through the Brief Addiction Monitor (BAM), the Craving Scale (CS), the Subjective Opiate Withdrawal Scale (SOWS), Substance Use Report, and a Brief Pain Inventory
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara MacIntyre MSN,RN, Mclean Hospital
- Investigators
- Barbara A MacIntyre, MSN,RN, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033746
- Sponsor's protocol ID
- 2013P001595
- Status last verified
- Feb 2018
- First submitted
- 3 Jan 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study Using Transdermal Electroacupuncture as Adjunctive Treatment to Reduce Opiate Cravings in Post-Detox Outpatients Receiving Buprenorphine-Naloxone
- ClinicalTrials.gov ID
- NCT02033746
- Acronym / sponsor ID
- 2013P001595
- Conditions
- Opioid-use Disorder
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Jan 2014 (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.
Pilot study of 12 outpatients in early recovery from illicit drug use,post-detox and on buprenorphine-naloxone maintenance will be offered 12 TEAS adjunct treatments over 6 weeks(X2/week) to ascertain if they experience any improvement in mood,sleep,overall quality of life and decrease drug cravings ultimately while facing everyday life stressors.
Detailed description
- this crossover study will involve participants who will be randomized into two treatment groups,A\&B. TEAS treatments will be given for 30 minutes,X2/week,for 6 weeks(12total sessions). Group A will receive 2 weeks(4 sessions) of active treatment followed by 4 weeks of sham treatment(8 sessions). Group B will receive 2 weeks(4 sessions) of sham treatment,2 weeks (4 sessions)of real treatment,and finally 2 weeks (4 sessions) of sham treatment.
- parameters to be measured include vital signs and questionnaires weeks 1,3,5,6 to assess self-reported past 14-day substance use,alcohol and drug craving,withdrawal symptoms,sleep,mood,pain and overall quality of life.
- goals include better lives for post-detox opiate addicts as they incorporate this treatment into their lives,saving themselves and loved ones more horror,and their communities resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transdermal Electroacupuncture - Arm A | Experimental | Device: Han's Acupoint Nerve Stimulatorweek 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator while receiving concurrent buprenorphine-naloxone as prescribed |
| Transdermal Electroacupuncture - Arm B | Experimental | Device: Han's Acupoint Nerve Stimulatorweek 1-2 real treatment, week 3-6 sham treatment with Han's Acupoint Nerve Stimulator treatment while receiving concurrent buprenorphine-naloxone as prescribed |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-59 years old
- early recovery(0-3months of abstinence
- not currently detoxing
- maintained on buprenorphine-naloxone under the care of qualified MD
- proficient in the English language
Key exclusion criteria (5 listed)
- having acute,psychiatric symptoms which would pose safety concerns,or an adherence to treatment barrier(active suicidality/psychosis/mania)
- severe cognitive disorders*not competent to give informed consent
- active cardiac disease or EKG abnormalities or with cardiac pacemaker
- currently detoxing from alcohol or illicit drugs
- inability or non-intention to attend all treatment sessions*history of seizures*pregnancy or breast feeding.
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 |
|---|---|---|
| Han's Acupoint Nerve Stimulatorfrequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method). | Device | Transdermal Electroacupuncture - Arm A, Transdermal Electroacupuncture - Arm B |
Primary outcome
Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions
Time frame: 6 weeks
4 secondary outcomes
Number of participants who experience improvement in mood
Time frame: 6 weeks
Number of participants who experience improvement in sleep
Time frame: 6 weeks
Number of participants who experience improvement in Quality-of-Life
Time frame: 6 weeks
Number of participants who report fewer cravings for drugs and alcohol
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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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.
Barbara A MacIntyre, MSN,RN principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Han's Acupoint Nerve Stimulator in people with Opioid-use Disorder, run by Mclean Hospital at 1 site in United States.
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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 22 Feb 2018. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.