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SREC for Nicotine Addiction (NIDA-SREC Trial)

N/A
Waitlist Available
Led By Neal L. Benowitz, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

NIDA-SREC Trial Summary

This trial will study the effects of two types of cigarettes on people's health, behaviors, and chemical exposure.

Eligible Conditions
  • Nicotine Addiction
  • Tobacco Poisoning
  • Cigarette Addiction
  • Cardiovascular Risk
  • Nicotine Withdrawal

NIDA-SREC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
Change in Mean score on the Positive and Negative Affect Scale (PANAS)
+5 more
Secondary outcome measures
Changes in mean blood pressure
Changes in mean circadian heart rate
Changes in mean urinary catecholamine
+3 more

NIDA-SREC Trial Design

3Treatment groups
Experimental Treatment
Group I: Standardized Dual UseExperimental Treatment1 Intervention
Four days of SREC and/or usual product use as regular with daily diary. Admitted to hospital research ward on Day 5 and 6 for 2 hospital day visits that includes ad libitum SREC use and less than usual amount of cigarette use; CV monitoring, 12-hr urine collections, and 12-hr circadian blood draws.
Group II: SREC only or cigarette only useExperimental Treatment1 Intervention
Four days of SREC/Usual cigarette/product use as regular with daily diary. Admitted to hospital research ward on Day 5 and 6 for 2 hospital day visits that includes a standardized session of product use; 4-hr abstinence; pharmacokinetic (PK) blood draws; ad libitum use of product; cardiovascular (CV) monitoring, 12-hr urine collections, and 12-hr circadian blood draws.
Group III: Alternate product from Arm 1Experimental Treatment1 Intervention
Four days of SREC/Usual cigarette/product use as regular with daily diary. Admitted to hospital research ward on Day 5 and 6 for 2 hospital day visits that includes a standardized session of product use; 4-hr abstinence; PK blood draws; ad libitum use of product; CV monitoring, 12-hr urine collections, and 12-hr circadian blood draws.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,500 Previous Clinical Trials
15,236,488 Total Patients Enrolled
2 Trials studying Nicotine Addiction
991 Patients Enrolled for Nicotine Addiction
National Institutes of Health (NIH)NIH
2,694 Previous Clinical Trials
6,952,522 Total Patients Enrolled
3 Trials studying Nicotine Addiction
327 Patients Enrolled for Nicotine Addiction
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,593 Total Patients Enrolled
15 Trials studying Nicotine Addiction
2,130 Patients Enrolled for Nicotine Addiction

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study open to participants aged 75 and above?

"This clinical trial is only open to patients between 21 and 70 years old. For those younger than 18 or older than 65, there are 7 trials available for the former age group and 138 trails offered for the latter."

Answered by AI

What objectives are researchers striving for with this clinical trial?

"This two-year clinical trial has the primary goal of measuring changes in mean scores on the Questionnaire for Smoking Urges (QSU-Brief). Other objectives include comparing the specificity of anabasine or nicotelline to nicotine metabolites and analysing levels of exposure to tobacco smoke toxins between dual SREC-TC use and TC-only use. Lastly, researchers will compare changes in blood pressure between SREC-only and TC-only usage."

Answered by AI

To what extent do the prerequisites for participating in this trial extend?

"A total of 20 nicotine-dependent adults, aged between 21 and 70, are able to join this trial. Additionally, they must possess a heart rate lower than 105 beats per minute, systolic blood pressure below 160 and above 90 as well as diastolic blood pressure no greater than 100 but at least 50. The BMI should not exceed 38.0 while the carbon dioxide level in their expired air is 5ppm or higher. Applicants also need to have been dual users (both electronic cigarettes and tobacco cigarettes) for at least 10 days prior within the last month's time with an inclination towards nonmenthol flavored e-cigarettes"

Answered by AI

Are new participants still being accepted for this exploration?

"Yes, the clinical trial is still active and enrolling. According to the data posted on clinicaltrials.gov, it was initially released in August 1st 2022 and has been updated as recently as August 24th of that same year. The study requires 20 individuals from two separate medical sites for its completion."

Answered by AI

How many participants are being included in this research?

"Affirmative. The information provided on clinicaltrials.gov confirms that recruitment for this medical trial, which was first publicised on August 1st 2022, is currently underway. Approximately 20 patients are being sought from two separate sites."

Answered by AI
~0 spots leftby Mar 2026