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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3DA063344-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this sham-controlled pilot randomized controlled trial (RCT) is to evaluate the feasibility, safety, and preliminary efficacy of a one-month intervention consisting of 20 home-based active or sham RS-tDCS sessions paired with audio track guided mindfulness meditation practice in otherwise healthy adults seeking to reduce cannabis use in the context of cannabis use disorder (CUD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Participants will complete 20 remotely supervised (RS) daily sessions, each 20 minutes, of active dorsolateral prefrontal cortex (DLPFC) tDCS combined with mindfulness meditation. |
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| Sham tDCS | Active Comparator | Participants will complete 20 RS sham sessions, each 20 minutes, of active DLPFC tDCS combined with mindfulness meditation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Transcranial Direct Current Stimulation (tDCS) | Device | tDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout the session (19 minutes), and then ramp down (for 30 seconds) at the end. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants who complete at least 70% (14 out of 20) of intervention sessions | End of treatment (up to 6 weeks) | |
| The proportion of participants who discontinue due to adverse effects | End of treatment (up to 6 weeks) | |
| The proportion of participants with no serious adverse events | End of treatment (up to 6 weeks) | |
| Change in cannabis use frequency, measured by the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU) | The DFAQ-CU is a self-report scale used to assess cannabis use behaviors. It measures frequency, quantity, age of onset, and daily sessions of cannabis use, including different forms like dry product, concentrates, and edibles. The DFAQ-CU also includes visual aids and questions about methods of cannabis administration and tetrahydrocannabinol (THC) levels. Questions 2-3, 6-12 assess frequency. | Baseline, End of treatment (up to 6 weeks) |
| Change in daily cannabis use, measured by the Timeline Followback (TLFB) method assessment | Daily cannabis use is assessed using the TLFB method, a validated self-report instrument used to collect retrospective estimates of daily cannabis use. | Baseline, End of treatment (up to 6 weeks) |
| Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS) | The CWS assesses withdrawal 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 withdrawal symptoms have a larger negative impact on normal daily activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cannabis craving, measured by the Marijuana Craving Questionnaire (MCQ-17) | Baseline, 1-month follow-up | |
| Change in psychological distress as measured by the Kessler Psychological Distress Scale (K10) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shayna Pehel | Contact | 929-455-5104 | Shayna.Pehel@nyulangone.org | |
| Giuseppina Pilloni | Contact | 929-455-5317 | Giuseppina.Pilloni@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Leigh Charvet, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
Individual participant data (IPD) will not be shared due to the small sample size and risk of re-identification.
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Sham Transcranial Direct Current Stimulation (tDCS) | Device | tDCS is a noninvasive brain stimulation device that modulates brain activity by delivering low-intensity electrical current (2.0 mA) through scalp sponge electrodes. Device is programmed to ramp up to 2.0 mA (for 30 seconds) followed by a ramp down (30 seconds), with no current delivery for 18 minutes, and then ramp up (for 30 seconds) and down (for 30 seconds) at the end. |
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| Mindfulness meditation | Behavioral | Participants will follow an audio track for guided mindfulness during the stimulation. |
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| Baseline, End of treatment (up to 6 weeks) |
| Baseline, 1-month follow-up |
| Change in anxiety as measured by State-Trait Anxiety Inventory (STAI) | The STAI is a psychological tool used to measure both state anxiety (temporary feelings of nervousness) and trait anxiety (a general tendency to be anxious). It's a 40-item self-report questionnaire, 20 items allocated to each of the S-Anxiety and T-Anxiety subscales, that uses a 4-point Likert scale. Item scores are added to obtain subtest total scores. Scoring should be reversed for anxiety-absent items (19 items of the total 40). Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. | Baseline, 1-month follow-up |
| Change in function as measured by the Marijuana Problem Scale (MPS) | The MPS (form AS5) is a self-report assessment that helps the patient identify areas their life affected by marijuana use. It contains 19 items that represent potential negative effects of marijuana on social relationships, self-esteem, motivation and productivity, work and finances, physical health, memory impairment, and legal problems. Items are rated either 0 (Not a problem), 1 (A minor problem), or 2 (A serious problem). Higher scores generally indicate more serious problems with marijuana. | Baseline, 1-month follow-up |
| Change in depression as measured by the Beck Depression Inventory (BDI) | BDI is a 21-item self-report scale designed to measure the severity of depressive symptoms. Each item is scored 0-3. The total score range is 0-63; the higher the score, the more severe the depression. A score > 40 indicates extreme depression. | Baseline, 1-month follow-up |
| Change in cannabis use frequency, measured by the Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis-Use Inventory (DFAQ-CU) | The DFAQ-CU is a self-report scale used to assess cannabis use behaviors. It measures frequency, quantity, age of onset, and daily sessions of cannabis use, including different forms like dry product, concentrates, and edibles. The DFAQ-CU also includes visual aids and questions about methods of cannabis administration and THC levels. Questions 2-3, 6-12 assess frequency. | Baseline, 1-month follow-up |
| Change in daily cannabis use, measured by the Timeline Followback Method Assessment (TLFB) | Daily cannabis use is assessed using the TLFB method, a validated self-report instrument used to collect retrospective estimates of daily cannabis use. | Baseline, 1-month follow-up |
| Change in cannabis withdrawal symptoms, measured by the Cannabis Withdrawal Scale (CWS) | The CWS assesses withdrawal 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 withdrawal symptoms have a larger negative impact on normal daily activities. | Baseline, 1-month follow-up |