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Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)

Primary Purpose

Hiv, Tobacco Smoking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TBS
Sham TMS
Sponsored by
Gopalkumar Rakesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hiv

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Potential participants will be

  • Patients enrolled in the Bluegrass Clinic
  • 18-60 years of age
  • Male or female gender
  • Able to read, understand and communicate in English
  • Willing to adhere to the general rules of the Bluegrass Clinic/SMARTClinic/Beyond Birth Clinic
  • Willing and able to abstain from drug use other than Suboxone
  • Exhaled breath on day of study carbon monoxide (CO) < 5 ppm
  • Stabilized on maintenance buprenorphine if having comorbid opioid use disorder.

Exclusion Criteria:

  • Positive pregnancy test for females, traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia, intracranial metal shrapnel.
  • Previous adverse effect with TMS.
  • Sub-threshold consistency while performing behavioral tasks.
  • Failure to show baseline attentional bias to smoking versus neutral cues.

Sites / Locations

  • 245 Fountain CourtRecruiting
  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TBS (Theta burst stimulation)

Sham TMS

Arm Description

Four sessions of TBS in one day

Four sessions of sham TMS

Outcomes

Primary Outcome Measures

Gaze Fixation on Smoking Cues
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Gaze Fixation on Smoking Cues
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Craving for cigarettes
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 48, min score is 0. Higher score means that craving is higher.
Craving for cigarettes
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 48, min score is 0. Higher score means that craving is higher.

Secondary Outcome Measures

Functional connectivity changes
Changes in functional connectivity measured using z score on functional MRI brain scan.
Functional connectivity changes
Changes in functional connectivity measured using z score on functional MRI brain scan.

Full Information

First Posted
February 10, 2022
Last Updated
February 6, 2023
Sponsor
Gopalkumar Rakesh
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05295953
Brief Title
Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
Official Title
Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gopalkumar Rakesh
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To demonstrate whether four sessions of TBS improves attentional bias and craving in PLWHA smokers compared to four sessions of sham stimulation. We hypothesize 4 sessions of TBS to the left DLPFC will significantly improve attentional bias and craving for smoking cues compared to neutral cues in a population of subjects who are smokers with HIV/AIDS compared to sham stimulation.
Detailed Description
The proposed pilot study seeks to explore modulation of attentional bias and tobacco craving in PLWHA with one session of adequately dosed theta burst stimulation (TBS). Results of this trial will spur clinical research to further investigate the use of TBS as an adjunctive smoking cessation aid for PLWHA and could have broad implications for smoking cessation programs. Data obtained from this pilot study will also facilitate resubmission of a grant application examining adjunctive theta burst stimulation (TBS) combined with varenicline for smoking cessation in PLWHA. People living with HIV/AIDS (PLWHA) smoke at nearly three times the rate of the general population. These extraordinary smoking rates are associated with greater AIDS-related morbidity, non-AIDS related morbidity including non-AIDS-defining cancer, cardiovascular disease, pulmonary disease, and mortality. Smoking significantly impacts the progression and outcome of HIV disease and has been identified as the leading contributor to premature mortality in PLWHA. One study estimated PLWHA lose more years from smoking than from HIV infection. In our view, shared by others in the field, the single greatest health behavior change that could improve mortality is to assist smokers living with HIV/AIDS to quit smoking.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hiv, Tobacco Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Active group and sham group
Masking
ParticipantCare Provider
Masking Description
Participant will not know whether they receive active or sham TMS
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TBS (Theta burst stimulation)
Arm Type
Active Comparator
Arm Description
Four sessions of TBS in one day
Arm Title
Sham TMS
Arm Type
Placebo Comparator
Arm Description
Four sessions of sham TMS
Intervention Type
Device
Intervention Name(s)
TBS
Intervention Description
Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.
Intervention Type
Device
Intervention Name(s)
Sham TMS
Intervention Description
Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
Primary Outcome Measure Information:
Title
Gaze Fixation on Smoking Cues
Description
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Time Frame
On Day 1 of the study
Title
Gaze Fixation on Smoking Cues
Description
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Time Frame
On Day 1 of the study after intervention
Title
Craving for cigarettes
Description
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 48, min score is 0. Higher score means that craving is higher.
Time Frame
On day one of the study.
Title
Craving for cigarettes
Description
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 48, min score is 0. Higher score means that craving is higher.
Time Frame
Immediately after intervention (sessions of TBS or sham TMS) on day 1
Secondary Outcome Measure Information:
Title
Functional connectivity changes
Description
Changes in functional connectivity measured using z score on functional MRI brain scan.
Time Frame
on Day 1 of study
Title
Functional connectivity changes
Description
Changes in functional connectivity measured using z score on functional MRI brain scan.
Time Frame
Immediately after intervention (sessions of TBS or sham TMS) on day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Potential participants will be Patients enrolled in the Bluegrass Clinic 18-60 years of age Male or female gender Able to read, understand and communicate in English Willing to adhere to the general rules of the Bluegrass Clinic/SMARTClinic/Beyond Birth Clinic Willing and able to abstain from drug use other than Suboxone Exhaled breath on day of study carbon monoxide (CO) < 5 ppm Stabilized on maintenance buprenorphine if having comorbid opioid use disorder. Exclusion Criteria: Positive pregnancy test for females, traumatic brain injury, history of seizure disorder, history of or current diagnosis of schizophrenia, intracranial metal shrapnel. Previous adverse effect with TMS. Sub-threshold consistency while performing behavioral tasks. Failure to show baseline attentional bias to smoking versus neutral cues.
Facility Information:
Facility Name
245 Fountain Court
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gopalkumar Rakesh
Phone
859-382-7611
Email
gopalkumar.rakesh@uky.edu
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madona Elias
Phone
859-382-7611
Email
madona.elias@uky.edu

12. IPD Sharing Statement

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Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)

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