A Teleheath tDCS Approach to Decrease Cannabis Use

A Teleheath tDCS Approach to Decrease Cannabis Use: Towards Reducing Multiple Sclerosis Disability

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05005013

Enrollment

Registered

2021-08-13

Start date

2022-09-13

Completion date

2024-05-22

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis Use Disorder, Multiple Sclerosis

Brief summary

The study aims to evaluate the effect of Dorsolateral Prefrontal Cortex (DLPFC) Transcranial Direct Current Stimulation (tDCS) in decreasing distress and cannabis use. 46 participants with Relapse Remitting Multiple Sclerosis (RRMS), Cannabis Use Disorder (CUD) and elevated distress (K10 score of 10-35) will be recruited.

Interventions

OTHERTranscranial Direct Current Stimulation (tDCS)

tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp.

OTHERSham - Transcranial Direct Current Stimulation (tDCS)

The tDCS device is programmed to mimic active tDCS.

OTHERMindfulness

Participants will follow an audio track for guided mindfulness during the stimulation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 65 Years

Healthy volunteers

Inclusion criteria

1. Ages 21-65 (inclusive) 2. Seeking treatment to reduce or discontinue current cannabis use (smoke/vape/ingest) 3. Current Cannabis Use Disorder per DSM-V (MINI for DSM-V) 4. K10 score 10-35, inclusive (mild to high moderate distress) 5. Definite MS diagnosis, relapsing remitting (RRMS) subtype 6. PDDS score 0-7 (mild to moderate neurological disability, established to be able to complete procedures) 7. All medications stable for ≥ 1 month prior to enrollment and throughout the trial 8. Ability to understand the informed consent process and provide consent to participate in the study 9. Stable and continuous access to internet service, email (WiFi hotspot to be provided if needed) 10. Ability to use mobile devices 11. Fluent in English language (due to outcomes validated in English versions only) 12. WRAT-4 score ≥ 85

Exclusion criteria

1. MS clinical relapse or use of high dose of steroids in the past month 2. Patients under medical marijuana use prescribed by a clinician 3. Alcohol, tobacco, or substance use disorder other than cannabis 4. Primary neurologic, psychiatric or other medical disorder other than MS (entry MD screening) 5. Currently meets DSM-V criteria for moderate or severe substance use disorder in the past 6 months for any psychoactive substance. 6. Meets DSM-V criteria for current panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, dissociate disorders, and any other psychotic disorder or organic mental disorder 7. Current suicidal ideation or deemed to be of potential risk of self-injury 8. History of traumatic brain injury 9. Seizure disorder or recent (\<5 years) seizure history 10. Metal implants in the head or neck 11. Enrolled in group or individual therapy for substance use disorder concurrent to intervention 12. Any skin disorder or skin sensitive area near stimulation locations 13. Pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame	Description
Change in Number of Monthly Sessions of Cannabis Use	Baseline, End of Intervention (Week 4)	Self-reported measure.
Change in Kessler Psychological Distress Scale (K10) Score	Baseline, End of Intervention (Week 4)	K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores \< 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and \> 30 are likely to have a severe mental disorder.
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)	Baseline, End of Intervention (Week 4)	The PA subscale includes 10 items describing positive mood states (e.g., enthusiastic, interested, proud), each rated on a Likert scale from 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 5-50; higher scores indicate greater levels of positive affect, reflecting an individual's engagement, energy, and pleasurable involvement with the environment.
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)	Baseline, End of Intervention (Week 4)	The NA subscale consists of 10 items representing negative mood states (e.g., upset, nervous, hostile), each rated on a 5-point Likert scale from 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 5-50; higher scores reflect greater levels of negative affect, capturing distress and unpleasurable engagement with the environment.
Change in Marijuana Craving Questionnaire (MCQ-17) Score	Baseline, End of Intervention (Week 4)	MCQ is a standardized measure assessing marijuana craving. Each statement is scored on a 7 point likert scale of 1 (strongly disagree) and 7 (strongly agree). Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. The total score is the average response score and ranges from 1-7; higher scored indicate greater levels of marijuana craving.
Change in Cannabis Withdrawal Scale (CWS) Score	Baseline, End of Intervention (Week 4)	The version of CWS used in the study asks about symptoms experienced over the last 24 hours and consists of 19 statements. For each statement, its negative impact on normal daily activities is rated on a likert scale from 0 (not at all) to 10 (extremely). The total score ranges from 0 to 190; higher scores indicate that symptoms are having a larger negative impact on normal daily activities.
Change in Number of Weekly Sessions of Cannabis Use	Baseline, End of Intervention (Week 4)	Self-reported measure.

Secondary

Measure	Time frame	Description
Change in Kessler Psychological Distress Scale (K10) Score	End of Intervention (Week 4), Month 3	K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores \< 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and \> 30 are likely to have a severe mental disorder.
Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)	End of Intervention (Week 4), Month 3	The PA subscale includes 10 items describing positive mood states (e.g., enthusiastic, interested, proud), each rated on a Likert scale from 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 5-50; higher scores indicate greater levels of positive affect, reflecting an individual's engagement, energy, and pleasurable involvement with the environment.
Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)	End of Intervention (Week 4), Month 3	The NA subscale consists of 10 items representing negative mood states (e.g., upset, nervous, hostile), each rated on a 5-point Likert scale from 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 5-50; higher scores reflect greater levels of negative affect, capturing distress and unpleasurable engagement with the environment.
Change in Marijuana Craving Questionnaire (MCQ-17) Score	End of Intervention (Week 4), Month 3	MCQ is a standardized measure assessing marijuana craving. Each statement is scored on a 7 point likert scale of 1 (strongly disagree) and 7 (strongly agree). Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. The total score is the average response score and ranges from 1-7; higher scored indicate greater levels of marijuana craving.
Change in Cannabis Withdrawal Scale (CWS) Score	End of Intervention (Week 4), Month 3	The version of CWS used in the study asks about symptoms experienced over the last 24 hours and consists of 19 statements. For each statement, its negative impact on normal daily activities is rated on a likert scale from 0 (not at all) to 10 (extremely). The total score ranges from 0 to 190; higher scores indicate that symptoms are having a larger negative impact on normal daily activities.
Change in Number of Weekly Sessions of Cannabis Use	End of Intervention (Week 4), Month 3	Self-reported measure.
Change in Number of Monthly Sessions of Cannabis Use	End of Intervention (Week 4), Month 3	Self-reported measure.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Active tDCS + Mindfulness Transcranial Direct Current Stimulation (tDCS): tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	22
Sham tDCS + Mindfulness Sham - Transcranial Direct Current Stimulation (tDCS): The tDCS device is programmed to mimic active tDCS. Mindfulness: Participants will follow an audio track for guided mindfulness during the stimulation.	13
Total	35

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Ineligibility	1	1
Overall Study	Lost to Follow-up	3	1
Overall Study	Withdrawal by Subject	5	1

Baseline characteristics

Characteristic	Active tDCS + Mindfulness	Total	Sham tDCS + Mindfulness
Age, Continuous	39 years STANDARD_DEVIATION 11	45.7 years STANDARD_DEVIATION 10.7	46.2 years STANDARD_DEVIATION 8.8
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	9 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants	25 Participants	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	11 Participants	16 Participants	5 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	3 Participants	2 Participants
Race (NIH/OMB) White	9 Participants	15 Participants	6 Participants
Region of Enrollment United States	22 participants	35 participants	13 participants
Sex: Female, Male Female	22 Participants	35 Participants	13 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 22	0 / 13
other Total, other adverse events	0 / 22	1 / 13
serious Total, serious adverse events	0 / 22	0 / 13

Outcome results

Primary

Change in Cannabis Withdrawal Scale (CWS) Score

The version of CWS used in the study asks about symptoms experienced over the last 24 hours and consists of 19 statements. For each statement, its negative impact on normal daily activities is rated on a likert scale from 0 (not at all) to 10 (extremely). The total score ranges from 0 to 190; higher scores indicate that symptoms are having a larger negative impact on normal daily activities.

Time frame: Baseline, End of Intervention (Week 4)

Arm	Measure	Value (MEAN)	Dispersion
Active tDCS + Mindfulness	Change in Cannabis Withdrawal Scale (CWS) Score	27.1 score on a scale	Standard Deviation 29.4
Sham tDCS + Mindfulness	Change in Cannabis Withdrawal Scale (CWS) Score	7 score on a scale	Standard Deviation 17.7

Primary

Change in Kessler Psychological Distress Scale (K10) Score

K10 is a 10-item questionnaire intended to yield a global measure of distress based on questions about anxiety and depressive symptoms that a person has experienced in the most recent 4 week period. Each question is given a score between 1 (none of the time) to 5 (all of the time). The total score ranges from 10 to 50. People with scores \< 20 are likely to be well, 20-24 are likely to have a mild mental disorder, 25-29 are likely to have moderate mental disorder, and \> 30 are likely to have a severe mental disorder.

Time frame: Baseline, End of Intervention (Week 4)

Arm	Measure	Value (MEAN)	Dispersion
Active tDCS + Mindfulness	Change in Kessler Psychological Distress Scale (K10) Score	6.4 score on a scale	Standard Deviation 6.1
Sham tDCS + Mindfulness	Change in Kessler Psychological Distress Scale (K10) Score	4.5 score on a scale	Standard Deviation 4.2

Primary

Change in Marijuana Craving Questionnaire (MCQ-17) Score

MCQ is a standardized measure assessing marijuana craving. Each statement is scored on a 7 point likert scale of 1 (strongly disagree) and 7 (strongly agree). Questions 1-7 measure compulsivity. Questions 8-11 measure emotionality. Questions 12-15 measure expectations. Questions 16-17 measure purposefulness. The total score is the average response score and ranges from 1-7; higher scored indicate greater levels of marijuana craving.

Time frame: Baseline, End of Intervention (Week 4)

Arm	Measure	Value (MEAN)	Dispersion
Active tDCS + Mindfulness	Change in Marijuana Craving Questionnaire (MCQ-17) Score	0.27 score on a scale	Standard Deviation 9.5
Sham tDCS + Mindfulness	Change in Marijuana Craving Questionnaire (MCQ-17) Score	0.8 score on a scale	Standard Deviation 9.7

Primary

Change in Number of Monthly Sessions of Cannabis Use

Self-reported measure.

Time frame: Baseline, End of Intervention (Week 4)

Arm	Measure	Value (MEAN)	Dispersion
Active tDCS + Mindfulness	Change in Number of Monthly Sessions of Cannabis Use	5.5 Sessions per month	Standard Deviation 9.1
Sham tDCS + Mindfulness	Change in Number of Monthly Sessions of Cannabis Use	3.33 Sessions per month	Standard Deviation 6.4

Primary

Change in Number of Weekly Sessions of Cannabis Use

Self-reported measure.

Time frame: Baseline, End of Intervention (Week 4)

Arm	Measure	Value (MEAN)	Dispersion
Active tDCS + Mindfulness	Change in Number of Weekly Sessions of Cannabis Use	1.36 Sessions per week	Standard Deviation 2.7
Sham tDCS + Mindfulness	Change in Number of Weekly Sessions of Cannabis Use	0.54 Sessions per week	Standard Deviation 1.9

Primary

Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)

The NA subscale consists of 10 items representing negative mood states (e.g., upset, nervous, hostile), each rated on a 5-point Likert scale from 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 5-50; higher scores reflect greater levels of negative affect, capturing distress and unpleasurable engagement with the environment.

Time frame: Baseline, End of Intervention (Week 4)

Arm	Measure	Value (MEAN)	Dispersion
Active tDCS + Mindfulness	Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)	-0.7 score on a scale	Standard Deviation 5.2
Sham tDCS + Mindfulness	Change in Positive and Negative Affect Schedule Score - Negative Affect (PANAS-NA)	3 score on a scale	Standard Deviation 4.3

Primary

Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)

The PA subscale includes 10 items describing positive mood states (e.g., enthusiastic, interested, proud), each rated on a Likert scale from 1 (very slightly or not at all) to 5 (extremely). The total score ranges from 5-50; higher scores indicate greater levels of positive affect, reflecting an individual's engagement, energy, and pleasurable involvement with the environment.

Time frame: Baseline, End of Intervention (Week 4)

Arm	Measure	Value (MEAN)	Dispersion
Active tDCS + Mindfulness	Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)	-1.3 score on a scale	Standard Deviation 8.3
Sham tDCS + Mindfulness	Change in Positive and Negative Affect Schedule Score - Positive Affect (PANAS-PA)	1.53 score on a scale	Standard Deviation 8.6

Secondary