Opioid-use Disorder
Conditions
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.
Interventions
DEVICEHan's Acupoint Nerve Stimulator
frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).
Sponsors
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants who attend all 12 Transdermal Electroacupuncture (TEAS) sessions | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience improvement in mood | 6 weeks | Mood measured by self-report on the Quick Inventory of Depressive Symptomatology (QIDS-SR-16) questionnaire. |
| Number of participants who experience improvement in sleep | 6 weeks | Sleep patterns measure by self report through the Pittsburgh Sleep Quality Index (PSQI) questionnaire |
| Number of participants who experience improvement in Quality-of-Life | 6 weeks | Quality-of-Life measured by self-report through Short Form (SF)-36 questionnaire |
| Number of participants who report fewer cravings for drugs and alcohol | 6 weeks | 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 |
Countries
United States
Outcome results
None listed