Cocaine Use DisorderPhase 2NCT04994821
TDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study
A Phase 2 study testing transcranial direct current stimulator (tDCS) and Cognitive Reappraisal in people with Cocaine Use Disorder and Cocaine Dependence, run by Soterix Medical at 1 site in United States.
Trial summary
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cocaine Use Disorder, Cocaine Dependence
- What is being tested?
- transcranial direct current stimulator (tDCS) and Cognitive Reappraisal
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 30 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-5 diagnosis of cocaine use disorder
- Ability to understand the risks/benefits of the study, provide informed consent and perform tasks as per protocol
- English speaking
- For females of childbearing capacity, current use of a medically acceptable form of birth control
Who cannot join
- Current or past history of a major neurological disorder (e.g. mental retardation, Parkinson's disease, Lewy body disease, Huntington's disease, MS, ALS, stroke, delirium tremens) or seizures, including those symptoms associated with periods of cocaine withdrawal or abstinence
- History of Axis I disorder, other than substance use disorder, that is associated with psychotic symptoms (e.g. schizophrenia) or neurodevelopmental disorder (e.g., autism)
- Use of medications (current or in the past 6 months) with known CNS effects or which may alter cerebral function, except psychotropics for depression/anxiety/PTSD (e.g. SSRIs)
- Clinically significant unstable medical illness or infection (e.g. HIV, hepatitis, etc.)
- Presence of contraindicated metallic implants or devices which may be impacted by electrical stimulation (e.g. cardiac pacemaker/defibrillator, medication pump, cochlear implant, implanted brain stimulator)
- Head trauma with loss of consciousness for more than 30 minutes
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: A Phase 2 Study to Investigate Use of Transcranial Direct Current Stimulation (tDCS) to Reduce Craving in Cocaine Addiction
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In a prior Phase-I study, the research team demonstrated feasibility of self-administration of a home-tDCS prototype in 14 patients that applied 15 sessions for each patient at an outpatient center.
Read the detailed description
The ultimate goal of this project is to develop a portable neuromodulatory intervention to reduce craving in cocaine addiction. This proposed project is in response to NIH/NIDA's solicitation titled "Development of Portable Neuromodulatory Device for the Treatment of Substance Use Disorders (SUDs)." The present study aims to increase the efficacy of repeated administration of tDCS to reduce drug craving in individuals with cocaine addiction.
Substance use disorders present a treatment challenge for clinicians, as well as a socioeconomic burden on individuals and society at large. Cocaine use disorder occurs when someone experiences clinically significant impairment caused by the recurrent use of cocaine, including health problems, physical withdrawal with discontinuation of use, persistent/escalating use, and failure to meet major personal, occupational, or educational responsibilities. At present, no FDA approved medicines are available to treat cocaine dependence, and behavioral therapy may be used to treat this addiction, though with limited efficacy. Drug craving (strong obsessions about and/or irresistible urges or compulsions to consume a drug) is a central driving force for perpetuation of substance use and subsequent addiction, as well as relapse after abstinence. Currently, no treatments exist that are targeted at reducing drug craving, which is intrusive and distressing to patients. The prefrontal cortex (PFC) plays an important role inhibiting these intrusive cravings. However, decades of data have shown that PFC activity is impaired in addictions. In this study, our goal is to increase PFC activity with non-invasive neuromodulation. Given the role of the PFC in the processing and regulation of craving behavior, this brain region is a key target for brain stimulation.
This study will recruit individuals with a diagnosis of cocaine use disorder (per DSM-5 criteria) who are receiving treatment for their substance use disorder at Samaritan Daytop Village (SDV) and other similar treatment facilities (e.g., Phoenix House, Mount Sinai's network of hospitals and clinics). Patients will be randomly assigned into three groups: active (real-tDCS), real-tDCS and Cognitive Reappraisal (CR), or sham (placebo) tDCS. Participants will receive 20 minutes of stimulation per tDCS day, three days per week for five weeks.
Interviews and neuropsychological testing will be conducted, and self-reported drug craving and addiction severity questionnaires will be used. Follow up cognitive and behavioral assessments will be conducted over a period of 12 months post tDCS stimulation. In addition, participants will be asked to perform EEG, cognitive tasks, and collection of a blood sample to assess genetic/epigenetic patterns
- Conditions
- Cocaine Use Disorder, Cocaine Dependence
- Being tested
- transcranial direct current stimulator (tDCS), Cognitive Reappraisal
- Keywords
- Transcranial Direct Current Stimulation, tDCS, Brain Stimulation, Cocaine Addiction, Drug Craving
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulator (tDCS)Device
Also called Soterix Medical mini-CT tDCS stimulator
Patients will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation.
Stimulation will last 20 minutes per day, three days per week, for 5 weeks
Cognitive ReappraisalBehavioural
Emotion regulation therapy
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Active Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator) Receives: Device: transcranial direct current stimulator (tDCS) |
| Sham tDCS | Sham comparator | Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator Receives: Device: transcranial direct current stimulator (tDCS) |
| Active tDCS with Cognitive Reappraisal (CR) | Experimental | Active Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR) Receives: Device: transcranial direct current stimulator (tDCS); Behavioral: Cognitive Reappraisal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)
Craving for cocaine will be assessed with a brief scale composed of 5 items (1, 2, 4, 5, and 13) from the Obsessive-Compulsive Cocaine Scale (OCCS; Vorspan et al., 2012).
Measured: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Secondary outcomes (5)
Change in Depression symptoms from Baseline (Ham-D score)
Depression symptoms will be assessed by the Hamilton Rating Scale for Depression (24 item version, HAM-D; Hamilton, 1960).
Measured: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Change in Anxiety symptoms from Baseline (HAM-A score)
Anxiety symptoms will be assessed by the Hamilton Rating Scale for Anxiety (HAM-A; Hamilton, 1959).
Measured: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Change in Quality of Life from Baseline (WHOQOL-BREF score)
An abbreviated instrument of cross-culturally valid assessment of quality of life of the World Health Organization (WHOQOL-BREF) with 26 questions (WHOQOL Group, 1998; Skevington et al., 2004) yields 4 domains (physical health, psychological, social relationships, and environment) and 2 individually scored items regarding overall perception of quality of life (Q1) and health (Q2). The 4 domain scores are scaled in a way that higher scores stand for higher quality of life.
Measured: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
EEG Late Positive Potential from Baseline
The Late Positive Potential (LLP), also known as the Late Positive Wave, is an Event Related Potential (ERP) that is formed approximately 400 ms after exposure to a stimulus and continues until about 2 s after the exposure. Higher LPP amplitude has been shown to indicate a higher level of cocaine craving (Parvaz 2016). We will present images of cocaine-related tasks to subjects and measure the amplitude of the LPP using a 64-electrode EEG cap. We will compare the LPP amplitude at each testing session to baseline amplitude.
Measured: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Urine Test Analysis from Baseline
Testing for the presence of cocaine in urine samples
Measured: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start28 Sep 2020
- Primary completion31 Mar 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cocaine Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soterix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor
- Investigators
- Abhishek Datta, PhD, Principal investigator, Soterix Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994821
- Sponsor's protocol ID
- SMIMS09282020
- Other IDs
- HS# 18-01324, GCO# 18-1920
- Status last verified
- Nov 2024
- First submitted
- 28 Jul 2021
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Batista EK, Klauss J, Fregni F, Nitsche MA, Nakamura-Palacios EM. A Randomized Placebo-Controlled Trial of Targeted Prefrontal Cortex Modulation with Bilateral tDCS in Patients with Crack-Cocaine Dependence. Int J Neuropsychopharmacol. 2015 Jun 10;18(12):pyv066. doi: 10.1093/ijnp/pyv066.
PubMed 26065432Agarwal S, Pawlak N, Cucca A, Sharma K, Dobbs B, Shaw M, Charvet L, Biagioni M. Remotely-supervised transcranial direct current stimulation paired with cognitive training in Parkinson's disease: An open-label study. J Clin Neurosci. 2018 Nov;57:51-57. doi: 10.1016/j.jocn.2018.08.037. Epub 2018 Sep 5.
PubMed 30193898Charvet LE, Dobbs B, Shaw MT, Bikson M, Datta A, Krupp LB. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, sham-controlled trial. Mult Scler. 2018 Nov;24(13):1760-1769. doi: 10.1177/1352458517732842. Epub 2017 Sep 22.
PubMed 28937310Charvet L, Shaw M, Dobbs B, Frontario A, Sherman K, Bikson M, Datta A, Krupp L, Zeinapour E, Kasschau M. Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Neuromodulation. 2018 Jun;21(4):383-389. doi: 10.1111/ner.12583. Epub 2017 Feb 22.
PubMed 28225155Moeller SJ, Zilverstand A, Konova AB, Kundu P, Parvaz MA, Preston-Campbell R, Bachi K, Alia-Klein N, Goldstein RZ. Neural Correlates of Drug-Biased Choice in Currently Using and Abstinent Individuals With Cocaine Use Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 May;3(5):485-494. doi: 10.1016/j.bpsc.2017.11.001. Epub 2017 Nov 11.
PubMed 29735157Parvaz MA, Moeller SJ, Goldstein RZ. Incubation of Cue-Induced Craving in Adults Addicted to Cocaine Measured by Electroencephalography. JAMA Psychiatry. 2016 Nov 1;73(11):1127-1134. doi: 10.1001/jamapsychiatry.2016.2181.
PubMed 27603142
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Investigate Use of Transcranial Direct Current Stimulation (tDCS) to Reduce Craving in Cocaine Addiction
- ClinicalTrials.gov ID
- NCT04994821
- Acronym / sponsor ID
- SMIMS09282020
- Conditions
- Cocaine Use Disorder, Cocaine Dependence
- Keywords
- Transcranial Direct Current Stimulation, tDCS, Brain Stimulation, Cocaine Addiction, Drug Craving
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Soterix MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which low level electrical currents are applied to the scalp in order to alter brain function. In a prior Phase-I study, the research team demonstrated feasibility of self-administration of a home-tDCS prototype in 14 patients that applied 15 sessions for each patient at an outpatient center.
Detailed description
The ultimate goal of this project is to develop a portable neuromodulatory intervention to reduce craving in cocaine addiction. This proposed project is in response to NIH/NIDA's solicitation titled "Development of Portable Neuromodulatory Device for the Treatment of Substance Use Disorders (SUDs)." The present study aims to increase the efficacy of repeated administration of tDCS to reduce drug craving in individuals with cocaine addiction.
Substance use disorders present a treatment challenge for clinicians, as well as a socioeconomic burden on individuals and society at large. Cocaine use disorder occurs when someone experiences clinically significant impairment caused by the recurrent use of cocaine, including health problems, physical withdrawal with discontinuation of use, persistent/escalating use, and failure to meet major personal, occupational, or educational responsibilities. At present, no FDA approved medicines are available to treat cocaine dependence, and behavioral therapy may be used to treat this addiction, though with limited efficacy. Drug craving (strong obsessions about and/or irresistible urges or compulsions to consume a drug) is a central driving force for perpetuation of substance use and subsequent addiction, as well as relapse after abstinence. Currently, no treatments exist that are targeted at reducing drug craving, which is intrusive and distressing to patients. The prefrontal cortex (PFC) plays an important role inhibiting these intrusive cravings. However, decades of data have shown that PFC activity is impaired in addictions. In this study, our goal is to increase PFC activity with non-invasive neuromodulation. Given the role of the PFC in the processing and regulation of craving behavior, this brain region is a key target for brain stimulation.
This study will recruit individuals with a diagnosis of cocaine use disorder (per DSM-5 criteria) who are receiving treatment for their substance use disorder at Samaritan Daytop Village (SDV) and other similar treatment facilities (e.g., Phoenix House, Mount Sinai's network of hospitals and clinics). Patients will be randomly assigned into three groups: active (real-tDCS), real-tDCS and Cognitive Reappraisal (CR), or sham (placebo) tDCS. Participants will receive 20 minutes of stimulation per tDCS day, three days per week for five weeks.
Interviews and neuropsychological testing will be conducted, and self-reported drug craving and addiction severity questionnaires will be used. Follow up cognitive and behavioral assessments will be conducted over a period of 12 months post tDCS stimulation. In addition, participants will be asked to perform EEG, cognitive tasks, and collection of a blood sample to assess genetic/epigenetic patterns
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: transcranial direct current stimulator (tDCS)Active Transcranial Direct Current Stimulation (tDCS), (Soterix Medical mini-CT tDCS stimulator) |
| Sham tDCS | Sham comparator | Device: transcranial direct current stimulator (tDCS)Sham (Placebo) Transcranial Direct Current Stimulation (tDCS), Soterix Medical mini-CT tDCS stimulator |
| Active tDCS with Cognitive Reappraisal (CR) | Experimental | Device: transcranial direct current stimulator (tDCS), Behavioral: Cognitive ReappraisalActive Transcranial Direct Current Stimulation (tDCS) (Soterix Medical mini-CT tDCS stimulator), and Cognitive Reappraisal (CR) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-5 diagnosis of cocaine use disorder
- Ability to understand the risks/benefits of the study, provide informed consent and perform tasks as per protocol
- English speaking
- For females of childbearing capacity, current use of a medically acceptable form of birth control
Key exclusion criteria (7 listed)
- Current or past history of a major neurological disorder (e.g. mental retardation, Parkinson's disease, Lewy body disease, Huntington's disease, MS, ALS, stroke, delirium tremens) or seizures, including those symptoms associated with periods of cocaine withdrawal or abstinence
- History of Axis I disorder, other than substance use disorder, that is associated with psychotic symptoms (e.g. schizophrenia) or neurodevelopmental disorder (e.g., autism)
- Use of medications (current or in the past 6 months) with known CNS effects or which may alter cerebral function, except psychotropics for depression/anxiety/PTSD (e.g. SSRIs)
- Clinically significant unstable medical illness or infection (e.g. HIV, hepatitis, etc.)
- Presence of contraindicated metallic implants or devices which may be impacted by electrical stimulation (e.g. cardiac pacemaker/defibrillator, medication pump, cochlear implant, implanted brain stimulator)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulator (tDCS)Also: Soterix Medical mini-CT tDCS stimulatorPatients will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation. Stimulation will last 20 minutes per day, three days per week, for 5 weeks | Device | Active tDCS, Active tDCS with Cognitive Reappraisal (CR), Sham tDCS |
| Cognitive ReappraisalEmotion regulation therapy | Behavioural | Active tDCS with Cognitive Reappraisal (CR) |
Primary outcome
Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score)
Time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Craving for cocaine will be assessed with a brief scale composed of 5 items (1, 2, 4, 5, and 13) from the Obsessive-Compulsive Cocaine Scale (OCCS; Vorspan et al., 2012).
5 secondary outcomes
Change in Depression symptoms from Baseline (Ham-D score)
Time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Change in Anxiety symptoms from Baseline (HAM-A score)
Time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Change in Quality of Life from Baseline (WHOQOL-BREF score)
Time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
EEG Late Positive Potential from Baseline
Time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Urine Test Analysis from Baseline
Time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Background: PubMed 26065432Batista EK, Klauss J, Fregni F, Nitsche MA, Nakamura-Palacios EM. A Randomized Placebo-Controlled Trial of Targeted Prefrontal Cortex Modulation with Bilateral tDCS in Patients with Crack-Cocaine Dependence. Int J Neuropsychopharmacol. 2015 Jun 10;18(12):pyv066. doi: 10.1093/ijnp/pyv066.
- Background: PubMed 30193898Agarwal S, Pawlak N, Cucca A, Sharma K, Dobbs B, Shaw M, Charvet L, Biagioni M. Remotely-supervised transcranial direct current stimulation paired with cognitive training in Parkinson's disease: An open-label study. J Clin Neurosci. 2018 Nov;57:51-57. doi: 10.1016/j.jocn.2018.08.037. Epub 2018 Sep 5.
- Background: PubMed 28937310Charvet LE, Dobbs B, Shaw MT, Bikson M, Datta A, Krupp LB. Remotely supervised transcranial direct current stimulation for the treatment of fatigue in multiple sclerosis: Results from a randomized, sham-controlled trial. Mult Scler. 2018 Nov;24(13):1760-1769. doi: 10.1177/1352458517732842. Epub 2017 Sep 22.
- Background: PubMed 28225155Charvet L, Shaw M, Dobbs B, Frontario A, Sherman K, Bikson M, Datta A, Krupp L, Zeinapour E, Kasschau M. Remotely Supervised Transcranial Direct Current Stimulation Increases the Benefit of At-Home Cognitive Training in Multiple Sclerosis. Neuromodulation. 2018 Jun;21(4):383-389. doi: 10.1111/ner.12583. Epub 2017 Feb 22.
- Background: PubMed 29735157Moeller SJ, Zilverstand A, Konova AB, Kundu P, Parvaz MA, Preston-Campbell R, Bachi K, Alia-Klein N, Goldstein RZ. Neural Correlates of Drug-Biased Choice in Currently Using and Abstinent Individuals With Cocaine Use Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2018 May;3(5):485-494. doi: 10.1016/j.bpsc.2017.11.001. Epub 2017 Nov 11.
- Background: PubMed 27603142Parvaz MA, Moeller SJ, Goldstein RZ. Incubation of Cue-Induced Craving in Adults Addicted to Cocaine Measured by Electroencephalography. JAMA Psychiatry. 2016 Nov 1;73(11):1127-1134. doi: 10.1001/jamapsychiatry.2016.2181.
- Soterix MedicalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhishek Datta, PhD principal investigator
Soterix Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing transcranial direct current stimulator (tDCS) and Cognitive Reappraisal in people with Cocaine Use Disorder and Cocaine Dependence, run by Soterix Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cocaine Craving from Baseline (Obsessive-Compulsive Cocaine Scale score) (time frame: Baseline (pre-tDCS), post-tDCS sessions (approx. week 6), Follow-up (1 month, 3 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04994821, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.