Smoking ( Cigarette)
Conditions
Brief summary
To determine if sucralose, an artificial sweetener, modulates nicotine threshold doses for discrimination, subjective-rewarding effects, and reinforcement in smokers with varying levels of dependence.
Detailed description
Participants will complete an Adaptation Session followed by four Test Days. The Adaptation Session will familiarize participants with all study procedures. On each Test Day, a specific intravenous nicotine dose (0.05 or 0.1 mg/pulse) is paired with either a sucralose or control flavor administered by an electronic cigarette. The experimental procedure begins with a sampling phase comparing the assigned nicotine dose against saline, each paired with the assigned flavor, followed by four trials to assess the participant's ability to discriminate between the two conditions. Subsequently, participants complete four Choice trials, where they will choose between receiving the assigned nicotine dose and saline. Reinforcement will be measured by the percentage of nicotine choices, while discrimination will be measured by the percentage of correctly identified infusions. Subjective rewarding effects will be assessed using the "Pleasurable Effects" composite score of the Drug Effects Questionnaire (DEQ).
Interventions
DRUGNicotine 0.05 mg/pulse and 0.1 mg/pulse
Nicotine will be used and compared to saline given by IV push by study physician
Saline will be used compared to the low dose of Nicotine given by IV push by study physician
DIETARY_SUPPLEMENTsucralose
sweet flavor (sucralose) compared to unsweetened flavor
DIETARY_SUPPLEMENTSugar syrup (Placebo)
Unsweetened flavor compared to the sweetened flavor sucralose.
Sponsors
Yale University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 59 Years
Healthy volunteers
No
Inclusion criteria
* Smoking at least for one year and more frequently than once a week, smoking status confirmed with a semi-quantitative urine nicotine test. Smokers will be stratified by level of dependence, assessed with the FTND 29 low or no dependence ≤3 and moderate or high dependence ≥ 4. * In good health as verified by medical history, screening examination, and screening laboratory tests. * For women, report using acceptable birth control methods.
Exclusion criteria
* History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study; * regular current use of certain psychotropic medications (such as mood stabilizers, antipsychotics, or anxiolytics being prescribed to treat bipolar disorder, psychosis or anxiety spectrum disorders, respectively); * current untreated alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine; * for women, pregnant as determined by pregnancy screening, or breastfeeding; and 5) seeking (or undergoing) treatment for tobacco dependence or smoking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug Discrimination Scale (DDS) score. | OnTest Days 1, 2, 3 and 4 | This scale asks the participants to select if they received Drug A or B and how confident they are in their selection on a scale of 0 to 10. Higher scores indicate more confidence. |
| Drug Effects Questionnaire (DEQ) pleasurable effects score | OnTest Days 1, 2, 3 and 4 | The DEQ pleasurable effects consists of 11 questions with total score range from 0-100. Higher scores indicate more positive effects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minnesota Nicotine Withdrawal Scale score | OnTest Days 1, 2, 3 and 4 | This 8-item scale will be used to assess DSM-IV symptoms of nicotine withdrawal. Total score range 0-32. Higher scores indicate more severe withdrawal symptoms. |
Countries
United States
Contacts
CONTACTMehmet Sofuoglu, M.D., Ph.D.
CONTACTStacy A Minnix, B.S.
PRINCIPAL_INVESTIGATORMehmet Sofuoglu, M.D., Ph.D.
Yale University
Outcome results
None listed