Trial Outcomes & Findings for Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction (NCT NCT01337297)

Results Overview

abstinence to the use of crack-cocaine up to 3 months after the completion of two-weeks of treatment sessions with active-tDCS or sham-tDCS.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Two days after the end of tDCS treatment (one session every other day, 5 sessions), that is, on the 12nd day from the beginning.

Results posted on

2014-01-30

Participant Flow

We started to recruit patients in 2011 in drug dependence specialized public outpatient service.

Of 70 patients, 20 filling including criteria and without excluding criteria were recruited. The remaining 50 either refused to participate or accepted but never showed up to the researcher center.

Participant milestones

Participant milestones
Measure	Active-tDCS low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).	Sham-tDCS the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session. transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).
Overall Study STARTED	11	9
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	5	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Active-tDCS low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).	Sham-tDCS the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session. transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).
Overall Study They entered to single anodal tDCS	4	3
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Prefrontal Cortex Stimulation as Treatment for Crack-cocaine Addiction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active-tDCS n=11 Participants low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).	Sham-tDCS n=9 Participants the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session. transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	30.5 years STANDARD_DEVIATION 7.3 • n=5 Participants	28.3 years STANDARD_DEVIATION 5.0 • n=7 Participants	29.5 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Brazil	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Two days after the end of tDCS treatment (one session every other day, 5 sessions), that is, on the 12nd day from the beginning.

abstinence to the use of crack-cocaine up to 3 months after the completion of two-weeks of treatment sessions with active-tDCS or sham-tDCS.

Outcome measures

Outcome measures
Measure	Active-tDCS n=7 Participants low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).	Sham-tDCS n=6 Participants the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session. transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).
Abstinence	71.4 percentage of participants	16.6 percentage of participants

SECONDARY outcome

Timeframe: before and after ERP in two weekly sessions over two weeks

The intensity of craving will be examined by a short scale, the Brief Cocaine Craving Questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: twice a week over two consecutive weeks during the treatment

Event Related Potentials (ERPs) elicited by random presentation of three related images and three non-related images to crack use every Monday and Friday over the two-weeks period of active-tDCS or sham-tDCS.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before the first experimental session, in the middle of the protocol and two days after the last experimental session

Cognitive tests are comprised by frontal assessment battery (FAB), Mini-Mental Status Examination (MMSE), verbal n-back task, visuospatial n-back task, go/no-go test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Before the first experimental session, in the middle of the treatment and after the last experimental session.

It will be applied Hamilton Scale for Depression, a structured multiple choice questionnaire used to assess the severity of the symptoms of depression. It will be applied with cognitive tests.

Outcome measures

Outcome data not reported

Adverse Events

Active-tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham-tDCS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ester Miyuki Nakamura-Palacios

Federal University of Espírito Santo

Phone: +55 27 7775-7337

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place