tDCS and Cognitive Training Intervention for Chronic Smokers With Schizophrenia

NCT03588728 | Terminated Results DMC

• 2 other identifiers: tDCSR21DA045137
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to develop new methods to help smokers with schizophrenia to successfully reduce their smoking and/or quit. This is not a treatment study, but will help find new techniques to create better treatments. Specifically, the investigators are interested in learning more about how thoughts and attention problems associated with schizophrenia might play a role in smoking, as well as the impact of cognitive (thinking, reasoning, and remembering) training and brain stimulation on these symptoms and on actual smoking.

Conditions

Transcranial Direct Current Stimulation; Smoking, Cigarette; Schizophrenia

Keywords

Transcranial Direct Current Stimulation; Smoking; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS™): MATRICS Consensus Cognitive Battery (MCCB)

  the MATRICS Consensus battery (MCCB) is a cognitive battery of tests for assessing cognition-enhancing treatments for schizophrenia through a broadly based scientific evaluation of measures. Change in cognitive measures of MATRICS Consensus Cognitive Battery (MCCB). Post-intervention minus baseline. Scale is scored 0-100. Difference score range is (-100 to 100) with positive scores reflecting improvement.

  Baseline to approximately 4 weeks

Secondary Outcomes (10)

• Cue-Reactivity

  Baseline to approximately 4 weeks

• Cigarette Puff Volume

  Baseline and at approximately 4 weeks

• Latency to First Cigarette Puff

  Baseline to approximately 4 weeks

• AX Version of the Continuous Performance Task (AX-CPT) Reaction Time

  Baseline to approximately 4 weeks

• AX Version of the Continuous Performance Task (AX-CPT) Reaction Time Variability

  Baseline to approximately 4 weeks

Study Arms (4)

CR + tDCS

EXPERIMENTAL

Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)

Other: Transcranial Direct Current Stimulation; Behavioral: Cognitive Remediation (CR)

CR + sham tDCS

SHAM COMPARATOR

Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)

Behavioral: Cognitive Remediation (CR)

control CR + tDCS

SHAM COMPARATOR

Control Cognitive Remediation (CR) and Transcranial Direct Current Stimulation (tDCS)

Other: Transcranial Direct Current Stimulation

control CR + sham tDCS

NO INTERVENTION

Control Cognitive Remediation (CR) and Sham Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation OTHER

Transcranial direct current stimulation targeting the right inferior frontal gyrus

Also known as: tDCS

CR + tDCS; control CR + tDCS

Cognitive Remediation (CR) BEHAVIORAL

Cognitive exercises on a computer designed to increase attention, memory, and processing speed.

CR + sham tDCS; CR + tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Currently meets DSM-5 criteria for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, or Delusional Disorder.
• Ability to provide written informed consent
• Smoke ≥ 7 cigarettes per day
• Expired breath CO ≥ 10 ppm at screening
• Stable medication regimen for ≥ 4 weeks (If on more than one psychotropic medication, main antipsychotic will be considered for stability)

You may not qualify if:

• Epilepsy or Current Seizure Disorder
• Pregnant or lactating
• Psychiatric hospitalization in past 3 months
• Suicidal and/or aggressive behavior past 3 months
• Implanted cardiac or brain medical devices
• Latex allergy
• Scalp irritation or recent shaving of scalp
• Use of other smoking cessation medication
• History of head trauma
• History of ECT

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pittsburgh Medical Center, Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Schizophrenia; Smoking

Interventions

Transcranial Direct Current Stimulation; Cognitive Remediation

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Behavior Therapy; Psychotherapy

Limitations and Caveats

Study was unexpectedly shut down prior to completing recruitment due to COVID-19 protocols.

Results Point of Contact

• Title: Cynthia Conklin, Ph.D.
• Organization: University of Pittsburgh

conkca@upmc.edu

4125869840

Study Officials

• Cynthia Conklin, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not informed of their randomization group until debreifing.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Model Details: 2 (CR, Control CR) x 2 (tDCS xSham tDCS)

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 17, 2018
• Study Start: July 23, 2018
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: March 13, 2023
• Results First Posted: March 13, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)