Effects of rTMS and tDCS Treatment on Brain Function, Craving and Relapse Prevention

Addiction Clinical Trial

Official title:

Effects of Noninvasive Brain Stimulation Methods (rTMS and tDCS) Treatment on Brain Function, Craving and Relapse Prevention

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03549065
• Other study ID #: MUSouthCarolina
• Status: Withdrawn
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Addiction is known as a chronic relapsing brain disorder that has a high cost to patients, family and society. Its ranking in cause of death is 8th globally, and substance abuse contributes 5.4% of the total global burden of disease. Brain stimulation procedures such as repetitive trans-cranial magnetic stimulation (rTMS) and trans-cranial direct current stimulation (tDCS) are considered minimal risk interventions and are used for the treatment of depression, pain, and other neurological and psychiatric disorders. There is some evidence that rTMS applied to the left prefrontal cortex results in significantly lowered craving. To date, no studies have investigated the effects of a course of either rTMS or tDCS treatment on opioid craving, brain function, and relapse prevention in opioid addicts. Individuals with prescription opioid dependence experience high rates of desire and intense cravings to use opioids. The present study aims to examine the effects of a course of daily prefrontal rTMS and tDCS on brain function, desire and craving and help to relapse prevention in abstinence phase.

Description:

The investigators plan to compare and contrast TMS and tDCS alone or in combination to treat opioid abuse. We will use a 4 cell randomised parallel controlled trial, consisting of active or sham TMS, and active or sham tDCS [a-tDCS, a-TMS; s-tDCS, a-TMS; a-tDCS, s-TMS; s-tDCS, s-TMS). The investigators hypothesise that each of the active interventions alone will be superior to pure sham in reducing craving and use. Moreover, The investigators hypothesise that COMBINING the two active treatments will be synergistic and will produce the largest reductions in craving and use.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• 40 treatment-seeking opioid-dependent subjects (between the ages of 21 and 65) with at least 30 days of abstinence under maintenance treatment will be included in this single blind study.

Exclusion criteria includes:

• history of seizures,

• receiving any medications known to lower seizure threshold,

• pregnancy,

• metal implants above the waist,

• brain lesions or tumors,

• a history of negative reactions to TMS, and

• a positive opioid urine screen (except methadone and suboxone

Related Conditions & MeSH terms

• Addiction

Intervention

Device:
• Brain Stimulation
Transcranial magnetic stimulation (TMS) is a minimally invasive brain stimulation method that stimulates the brain of an individual focally(George & Belmaker, 2007). TMS pulses that are delivered repetitively and rhythmically are referred to as repetitive TMS (rTMS). Transcranial direct current stimulation (tDCS) is another form of non-invasive brain stimulation that is being investigated as an intervention for neurological and psychiatric disorders. A weak direct electrical current (0-2 mA) flows between two small electrodes via saline soaked sponges placed on the scalp (Nitsche MA et al, 2008).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in craving and opioid relapse Using Opioid Cue panel	Using Opioid Cue panel	Day 1, 6 month