Opiate Craving Reduction Study Using Post-detox Patients on Suboxone and Use of TEAS as Adjunctive Treatment

Opioid-use Disorder Clinical Trial

Official title:

A Crossover Study Using Transdermal Electroacupuncture as Adjunctive Treatment to Reduce Opiate Cravings in Post-Detox Outpatients Receiving Buprenorphine-Naloxone

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02033746
• Other study ID #: 2013P001595
• Status: Withdrawn
• Phase: N/A
• First received: January 3, 2014
• Last updated: February 20, 2018
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Mclean Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 facing everyday life stressors.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Opioid-use Disorder

Intervention

Device:
• Han's Acupoint Nerve Stimulator
frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions		6 weeks
Secondary	Number of participants who experience improvement in mood	Mood measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16) questionnaire.	6 weeks
Secondary	Number of participants who experience improvement in sleep	Sleep patterns measure by self report through the Pittsburgh Sleep Quality Index (PSQI) questionnaire	6 weeks
Secondary	Number of participants who experience improvement in Quality-of-Life	Quality-of-Life measured by self-report through Short Form (SF)-36 questionnaire	6 weeks
Secondary	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	6 weeks