Hiv, Tobacco Smoking
Conditions
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.
Interventions
DEVICETBS
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.
DEVICESham TMS
Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
Sponsors
National Cancer Institute (NCI)
Gopalkumar Rakesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Participant will not know whether they receive active or sham TMS
Intervention model description
Active group and sham group
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gaze Fixation on Smoking Cues | On Day 1 of the study | Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome |
| Craving for Cigarettes | On day one of the study. | Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Showing Functional Connectivity Changes | on Day 1 of study | Changes in functional connectivity on a functional MRI brain scan. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TBS (Theta Burst Stimulation) Four sessions of TBS in one day
TBS: 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. | 2 |
| Sham TMS Four sessions of sham TMS
Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil. | 2 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Sham TMS | Total | TBS (Theta Burst Stimulation) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Continuous | 40.7 years STANDARD_DEVIATION 1.4 | 45.25 years STANDARD_DEVIATION 9.5 | 51.5 years STANDARD_DEVIATION 10.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 2 participants | 4 participants | 2 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Craving for Cigarettes
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher.
Time frame: On day one of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TBS (Theta Burst Stimulation) | Craving for Cigarettes | 58 units on a scale | Standard Deviation 5.66 |
| Sham TMS | Craving for Cigarettes | 50 units on a scale | — |
Primary
Craving for Cigarettes
Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TBS (Theta Burst Stimulation) | Craving for Cigarettes | 51 units on a scale | Standard Deviation 1.41 |
| Sham TMS | Craving for Cigarettes | 28 units on a scale | — |
Primary
Gaze Fixation on Smoking Cues
Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome
Time frame: On Day 1 of the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TBS (Theta Burst Stimulation) | Gaze Fixation on Smoking Cues | 320.19 milliseconds | Standard Deviation 234.83 |
| Sham TMS | Gaze Fixation on Smoking Cues | 152.60 milliseconds | — |
Primary
Gaze Fixation on Smoking Cues
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TBS (Theta Burst Stimulation) | Gaze Fixation on Smoking Cues | 221.75 milliseconds | Standard Deviation 94.24 |
| Sham TMS | Gaze Fixation on Smoking Cues | 120.50 milliseconds | — |
Secondary
Number of Participants Showing Functional Connectivity Changes
Changes in functional connectivity on a functional MRI brain scan.
Time frame: on Day 1 of study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TBS (Theta Burst Stimulation) | Number of Participants Showing Functional Connectivity Changes | 2 Participants |
| Sham TMS | Number of Participants Showing Functional Connectivity Changes | 1 Participants |