Clinical trial NCT02033746: Opiate Craving Reduction Study Using Post-detox Patients on Suboxone and Use of TEAS as Adjunctive Treatment
Official title: A Crossover Study Using Transdermal Electroacupuncture as Adjunctive Treatment to Reduce Opiate Cravings in Post-Detox Outpatients Receiving Buprenorphine-Naloxone
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid-use Disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of participants who experience improvement in mood
timeFrame: 6 weeks
measure: Number of participants who experience improvement in sleep
timeFrame: 6 weeks
measure: Number of participants who experience improvement in Quality-of-Life
timeFrame: 6 weeks
measure: Number of participants who report fewer cravings for drugs and alcohol
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Barbara A MacIntyre, MSN,RN
role: PRINCIPAL_INVESTIGATOR
References: