Trial Outcomes & Findings for Bilateral Prefrontal Modulation in Crack-cocaine Addiction (NCT NCT02091167)
NCT ID: NCT02091167
Last Updated: 2019-06-24
Results Overview
Five items from the original obsessive compulsive drinking scale, which are believed to reliably assess craving in a narrow sense were used. Questions of this brief scale allow quantification of thoughts and feelings (obsessions), and behavioral intentions, and are answered on a scale ranging from 0 to 4, resulting in a total score between 0 and 20. Higher scores reflect more severe craving. These items were applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Five applications: once in the week before tDCS treatment (baseline), second, third and fourth weeks, during the treatment, and in the fith week, after the end of the tDCS treatment.
Results posted on
2019-06-24
Participant Flow
There were two dropouts in the sham-tDCS group that were excluded after randomization. One patient escaped from the treatment facility and the other had to be discontinued because of precocious discharge from the clinic for misconduct.
Participant milestones
| Measure |
Real tDCS
Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).
transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.
|
Sham-tDCS
Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 30 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.
transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
16
|
|
Overall Study
COMPLETED
|
19
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Real tDCS
Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).
transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.
|
Sham-tDCS
Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 30 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.
transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Real tDCS
n=19 Participants
Ten sessions (every other day) of bilateral transcranial Direct Current Stimulation (tDCS: 2 milliamperes, 3 x 7 cm2, during 20 minutes) over dorsolateral Prefrontal Cortex (cathodal left / anodal right).
transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.
|
Sham-tDCS
n=14 Participants
Ten sessions (every other day) of placebo control (sham procedure) of transcranial Direct Current Stimulation (sham-tDCS) during 20 minutes with electrodes placed over the dorsolateral Prefrontal Cortex (cathodal left / anodal right). Current was delivered for 30 seconds and was turned off for the rest of the stimulation period. In this way, subjects experienced the initial itching sensation at the beginning of stimulation, but received no current for the rest of the session.
transcranial Direct Current Stimulation: Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 9.6 • n=19 Participants
|
35.0 years
STANDARD_DEVIATION 8.2 • n=14 Participants
|
35.03 years
STANDARD_DEVIATION 8.7 • n=33 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=19 Participants
|
2 Participants
n=14 Participants
|
6 Participants
n=33 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=19 Participants
|
12 Participants
n=14 Participants
|
27 Participants
n=33 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Years of education
Between 6 to 9
|
7 Participants
n=19 Participants
|
4 Participants
n=14 Participants
|
11 Participants
n=33 Participants
|
|
Years of education
Between 10 to 13
|
8 Participants
n=19 Participants
|
7 Participants
n=14 Participants
|
15 Participants
n=33 Participants
|
|
Years of education
Above 13
|
4 Participants
n=19 Participants
|
3 Participants
n=14 Participants
|
7 Participants
n=33 Participants
|
|
Employment situation
Formal job
|
2 Participants
n=19 Participants
|
4 Participants
n=14 Participants
|
6 Participants
n=33 Participants
|
|
Employment situation
Unemployed
|
9 Participants
n=19 Participants
|
8 Participants
n=14 Participants
|
17 Participants
n=33 Participants
|
|
Employment situation
Freelance
|
7 Participants
n=19 Participants
|
1 Participants
n=14 Participants
|
8 Participants
n=33 Participants
|
|
Employment situation
Retired
|
1 Participants
n=19 Participants
|
1 Participants
n=14 Participants
|
2 Participants
n=33 Participants
|
|
Marital state
Single
|
12 Participants
n=19 Participants
|
10 Participants
n=14 Participants
|
22 Participants
n=33 Participants
|
|
Marital state
Married
|
2 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
2 Participants
n=33 Participants
|
|
Marital state
Common-law
|
0 Participants
n=19 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=33 Participants
|
|
Marital state
Divorced
|
1 Participants
n=19 Participants
|
2 Participants
n=14 Participants
|
3 Participants
n=33 Participants
|
|
Marital state
Widow
|
0 Participants
n=19 Participants
|
1 Participants
n=14 Participants
|
1 Participants
n=33 Participants
|
|
Marital state
Non reported
|
4 Participants
n=19 Participants
|
0 Participants
n=14 Participants
|
4 Participants
n=33 Participants
|
|
Tobacco use
Yes
|
11 Participants
n=19 Participants
|
11 Participants
n=14 Participants
|
22 Participants
n=33 Participants
|
|
Tobacco use
No
|
8 Participants
n=19 Participants
|
3 Participants
n=14 Participants
|
11 Participants
n=33 Participants
|
PRIMARY outcome
Timeframe: Five applications: once in the week before tDCS treatment (baseline), second, third and fourth weeks, during the treatment, and in the fith week, after the end of the tDCS treatment.Population: Two patients from each group were lost to follow-up after their discharge from the hospital.
Five items from the original obsessive compulsive drinking scale, which are believed to reliably assess craving in a narrow sense were used. Questions of this brief scale allow quantification of thoughts and feelings (obsessions), and behavioral intentions, and are answered on a scale ranging from 0 to 4, resulting in a total score between 0 and 20. Higher scores reflect more severe craving. These items were applied at the beginning, during and at the end of the treatment with sham-tDCS or tDCS.
Outcome measures
| Measure |
Real-tDCS
n=19 Participants
Crack-cocaine patients who underwent 10 sessions of real tDCS treatment.
|
Sham-tDCS
n=14 Participants
Crack-cocaine patients who underwent sham (placebo)-tDCS control procedure.
|
|---|---|---|
|
Craving
1
|
6.53 scores on a scale
Standard Deviation 5.2
|
7.0 scores on a scale
Standard Deviation 3.8
|
|
Craving
2
|
4.74 scores on a scale
Standard Deviation 4.1
|
4.43 scores on a scale
Standard Deviation 2.9
|
|
Craving
3
|
3.63 scores on a scale
Standard Deviation 3.9
|
4.0 scores on a scale
Standard Deviation 3.2
|
|
Craving
4
|
2.63 scores on a scale
Standard Deviation 3.4
|
3.5 scores on a scale
Standard Deviation 3.1
|
|
Craving
5
|
2.26 scores on a scale
Standard Deviation 2.9
|
4.07 scores on a scale
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: 30 and 60 days after discharge from clinicsA use relapse was defined as the first episode of return to the previous uncontrolled pattern of crack-cocaine use (rocks per day). Information about relapse were gathered directly when patients regularly returned to the hospital for clinical follow-up after their discharge and/or by self-report or reports of family members by telephone calls.
Outcome measures
| Measure |
Real-tDCS
n=17 Participants
Crack-cocaine patients who underwent 10 sessions of real tDCS treatment.
|
Sham-tDCS
n=12 Participants
Crack-cocaine patients who underwent sham (placebo)-tDCS control procedure.
|
|---|---|---|
|
Relapses
30-days follow-up · Not relapsed
|
10 Participants
|
7 Participants
|
|
Relapses
30-days follow-up · Relapsed
|
7 Participants
|
5 Participants
|
|
Relapses
60-days follow-up · Not relapsed
|
8 Participants
|
4 Participants
|
|
Relapses
60-days follow-up · Relapsed
|
9 Participants
|
8 Participants
|
Adverse Events
Real-tDCS
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Sham-tDCS
Serious events: 0 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Real-tDCS
n=19 participants at risk
Crack-cocaine patients who underwent 10 sessions of real tDCS treatment.
|
Sham-tDCS
n=14 participants at risk
Crack-cocaine patients who underwent sham (placebo)-tDCS control procedure.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Tingling in the scalp
|
73.7%
14/19 • Number of events 14 • Adverse events were examined once at the end of each tDCS application. Therefore, over 10 tDCS applications, with a total of 10 examinations.
We asked subjects about the following adverse effects: headache, neck and scalp pain, tingling, itching, skin redness, burning sensation of the scalp, sleepiness, acute mood changes, trouble concentrating, and others after treatment.
|
50.0%
7/14 • Number of events 7 • Adverse events were examined once at the end of each tDCS application. Therefore, over 10 tDCS applications, with a total of 10 examinations.
We asked subjects about the following adverse effects: headache, neck and scalp pain, tingling, itching, skin redness, burning sensation of the scalp, sleepiness, acute mood changes, trouble concentrating, and others after treatment.
|
|
Nervous system disorders
Headache
|
0.00%
0/19 • Adverse events were examined once at the end of each tDCS application. Therefore, over 10 tDCS applications, with a total of 10 examinations.
We asked subjects about the following adverse effects: headache, neck and scalp pain, tingling, itching, skin redness, burning sensation of the scalp, sleepiness, acute mood changes, trouble concentrating, and others after treatment.
|
7.1%
1/14 • Number of events 1 • Adverse events were examined once at the end of each tDCS application. Therefore, over 10 tDCS applications, with a total of 10 examinations.
We asked subjects about the following adverse effects: headache, neck and scalp pain, tingling, itching, skin redness, burning sensation of the scalp, sleepiness, acute mood changes, trouble concentrating, and others after treatment.
|
|
Nervous system disorders
Drowsiness
|
5.3%
1/19 • Number of events 1 • Adverse events were examined once at the end of each tDCS application. Therefore, over 10 tDCS applications, with a total of 10 examinations.
We asked subjects about the following adverse effects: headache, neck and scalp pain, tingling, itching, skin redness, burning sensation of the scalp, sleepiness, acute mood changes, trouble concentrating, and others after treatment.
|
0.00%
0/14 • Adverse events were examined once at the end of each tDCS application. Therefore, over 10 tDCS applications, with a total of 10 examinations.
We asked subjects about the following adverse effects: headache, neck and scalp pain, tingling, itching, skin redness, burning sensation of the scalp, sleepiness, acute mood changes, trouble concentrating, and others after treatment.
|
|
Skin and subcutaneous tissue disorders
Burning sensation of the scalp
|
5.3%
1/19 • Number of events 1 • Adverse events were examined once at the end of each tDCS application. Therefore, over 10 tDCS applications, with a total of 10 examinations.
We asked subjects about the following adverse effects: headache, neck and scalp pain, tingling, itching, skin redness, burning sensation of the scalp, sleepiness, acute mood changes, trouble concentrating, and others after treatment.
|
0.00%
0/14 • Adverse events were examined once at the end of each tDCS application. Therefore, over 10 tDCS applications, with a total of 10 examinations.
We asked subjects about the following adverse effects: headache, neck and scalp pain, tingling, itching, skin redness, burning sensation of the scalp, sleepiness, acute mood changes, trouble concentrating, and others after treatment.
|
Additional Information
Dr. Ester Miyuki Nakamura-Palacios, Coordinator of Clinical Trials
Federal University of Espírito Santo
Phone: +55 27 3335-7337
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place