Trial Outcomes & Findings for Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers (NCT NCT02590640)

NCT ID: NCT02590640

Last Updated: 2022-07-13

Results Overview

Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ)

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

1 hour

Results posted on

2022-07-13

Participant Flow

Arms cannot be reported separately. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable.

Participant milestones

Participant milestones
Measure	All Participants Inhibitory insular rTMS group: Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. Repetitive transcranial magnetic stimulation, MagStim Rapid2: And Sham insular rTMS group: Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.
Overall Study STARTED	40
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insular Inhibitory Neuromodulation to Reduce Cigarette Craving and Alter Brain Function in Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=40 Participants Inhibitory insular rTMS group: Inhibitory (1 Hz) repetitive transcranial magnetic stimulation will be applied to the insula in smokers. Repetitive transcranial magnetic stimulation, MagStim Rapid2: And Sham insular rTMS group: Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Data cannot be reported. Data for this study was found to have been compromised. The PI responsible for the study has left the institution, and the data regarding randomization, outcome measures, and adverse events has been determined to be unreliable.

Cue-induced cigarette craving as assessed by Tobacco Craving Questionnaire (TCQ)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 hour

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 1 hour

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Research Services

University of Colorado Denver | Anschutz

Phone: 303-724-1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place