Active tDCSNCT02570763
Combining Non-Invasive Brain Stimulation With Cognitive Behavioral Intervention in Substance Use Disorder
A study testing Active tDCS stimulation in people with Active tDCS and Sham tDCS, run by University of Minnesota.
Trial summary
The current study aims to examine the safety and feasibility of utilizing tDCS to enhance affect-laden episodic memory consolidation among adults with co-occurring alcohol use and anxiety disorders who have recently undergone detoxification as a step toward the translational clinical application of this approach. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Active tDCS, Sham tDCS
- What is being tested?
- Active tDCS stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Jul 2016
- Phase
- Interventional
- 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 IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days
- DSM IV diagnosis of alcohol dependence within the last 30 days
- inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
- alcohol use in the 30 days preceding the study
- willingness to provide informed consent
- minimum of a sixth grade English reading level (deemed necessary to complete study materials); as determined by their being able to read and understand the consent form.
- Living within reasonable driving distance (1 hour or less) of the Twin Cities to allow for in-person follow-up interviews
Who cannot join
- lifetime history of psychosis or mania by history.
- cognitive (e.g., dementia) or physical impairment (e.g., blindness) that interferes with study participation report or as judged by PI/study physician.
- Current suicide risk as deemed by the PI and study physician to be serious and ongoing
- any medical condition or treatment with neurological sequelae (e.g., stroke, tumor, loss of consciousness of more than 30 minutes, HIV, seizures)
- history of ECT
- document loss of consciousness (LOC) for longer than 30 minutes or LOC with neurological sequelae
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- pregnancy
- Although seizures are not a known risk of tDCS intervention (Fregni et al., 2006; Nitsche et al., 2008), anyone with a history or a risk for seizures will be excluded from the study
- anyone with metal objects implanted in their head or neck
- anyone taking stimulant medications for any reason as we wish to avoid two sorces of neurostimulation
About this study
The current study aims to examine the safety and feasibility of utilizing tDCS to enhance affect-laden episodic memory consolidation among adults with co-occurring alcohol use and anxiety disorders who have recently undergone detoxification as a step toward the translational clinical application of this approach.
- Conditions
- Active tDCS, Sham tDCS
- Being tested
- Active tDCS stimulation, Sham tDCS stimulation
- Keywords
- neurostimulation, comorbidity, tDCS, CBT, anxiety, alcohol
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS stimulationDevice
Sham tDCS stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Experimental | Active tDCS administration during the first 20 minutes of each of the six therapy sessions. Receives: Device: Active tDCS stimulation |
| Sham Stimulation | Sham comparator | Sham tDCS administration during the first 20 minutes of each of six therapy sessions. Receives: Device: Sham tDCS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapy Content Memory Assessment
Participant's will complete daily assessments of their memory for therapy content from the previous session.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Why it stopped: The co-investigator and recipient of funding for the project left the department and we were unable to complete the study without her as a co-investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Active tDCSStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570763
- Sponsor's protocol ID
- 1508M77345
- Status last verified
- Nov 2017
- First submitted
- 6 Oct 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Non-Invasive Brain Stimulation With Cognitive Behavioral Intervention in Substance Use Disorder
- ClinicalTrials.gov ID
- NCT02570763
- Acronym / sponsor ID
- 1508M77345
- Conditions
- Active tDCS, Sham tDCS
- Keywords
- neurostimulation, comorbidity, tDCS, CBT, anxiety, alcohol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The co-investigator and recipient of funding for the project left the department and we were unable to complete the study without her as a co-investigator.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 7 Oct 2015 (estimated)
- 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.
The current study aims to examine the safety and feasibility of utilizing tDCS to enhance affect-laden episodic memory consolidation among adults with co-occurring alcohol use and anxiety disorders who have recently undergone detoxification as a step toward the translational clinical application of this approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Experimental | Device: Active tDCS stimulationActive tDCS administration during the first 20 minutes of each of the six therapy sessions. |
| Sham Stimulation | Sham comparator | Device: Sham tDCS stimulationSham tDCS administration during the first 20 minutes of each of six therapy sessions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- DSM IV diagnosis of panic disorder (with or without agoraphobia), generalized anxiety disorder, or social anxiety disorder within the past 30 days
- DSM IV diagnosis of alcohol dependence within the last 30 days
- inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
- alcohol use in the 30 days preceding the study
- willingness to provide informed consent
Key exclusion criteria (10 listed)
- lifetime history of psychosis or mania by history.
- cognitive (e.g., dementia) or physical impairment (e.g., blindness) that interferes with study participation report or as judged by PI/study physician.
- Current suicide risk as deemed by the PI and study physician to be serious and ongoing
- any medical condition or treatment with neurological sequelae (e.g., stroke, tumor, loss of consciousness of more than 30 minutes, HIV, seizures)
- history of ECT
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 |
|---|---|---|
| Active tDCS stimulation | Device | Active Stimulation |
| Sham tDCS stimulation | Device | Sham Stimulation |
Primary outcome
Therapy Content Memory Assessment
Time frame: 24 hours
Participant's will complete daily assessments of their memory for therapy content from the previous session.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS stimulation in people with Active tDCS and Sham tDCS, run by University of Minnesota.
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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Therapy Content Memory Assessment (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2017.