Addictive Threshold of Nicotine
ConditionSmoking Addiction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-59
SponsorYale University
About this trial
To determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, -and reinforcement in smokers with different levels of dependence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
to contact their primary care provider when necessary.
Adults, aged 21 to 59 years. Individuals less than 21 will be excluded because the minimum age for purchasing tobacco products is 21 in our state. The upper age is set at 59 because there are no previous IV nicotine studies that enrolled smokers over the age of 59.
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 based on the level of dependence, assessed with the FTND scores (Heatherton et al. 1991) (low or no dependence 4 and moderate or high level of dependence 5.
In good health as verified by medical history, screening examination, and screening laboratory tests.
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Nicotine
DrugNicotine will be infused using a pump.
Saline
Other interventionSaline with be used to compare Nicotine, Saline will be infused using a pump
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: NicotineActive comparator 2 interventions
Group B: salinePlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
correctly identifying nicotine
Reinforcement will be assessed with the percentage of nicotine doses chosen during the Choice trials (out of 16), 4 choices per day over four days.
Time frame
up to 8 weeksSponsors and contacts
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Yale University
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov