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Trials / Completed

CompletedNCT03670212

Investigation of Nicotine Seeking Behavior in Current Smokers

Neuropharmacological Investigation of Frontostriatal Network Function and Nicotine Seeking Behavior in Current Smokers

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Wayne State University · Academic / Other
Sex
All
Age
21 Years – 35 Years
Healthy volunteers
Not accepted

Summary

In this study, 21 non-treatment-seeking cigarette smokers were recruited to investigate the effects of acute stress on brain function and nicotine seeking/self-administration behavior.

Detailed description

Non-treatment-seeking cigarette smoking individuals were recruited from the Detroit, MI area. Individuals were screened for cardiovascular, neurological, and psychiatric contraindications. 21 healthy smokers completed two oral pre-treatment experimental sessions (on separate non-consecutive days) in randomized order under double-blind conditions: placebo (lactose) and stress (54mg yohimbine and 10mg hydrocortisone). Yohimbine + hydrocortisone elicit a neurochemical and physiological response that mimics a 'natural' stressor. Placebo and stress sessions were identical and started at 11am. Upon arrival, subject sobriety was confirmed with expired breath alcohol measurement (\<.02%). At 11:30am, each subject smoked 6 cigarette puffs (preferred brand; provided by study) over 5 minutes to control for recent nicotine exposure. Throughout each experimental session, subjects periodically completed self-reported measures of cigarette craving, nicotine withdrawal symptoms, affect, and anxiety, and vital signs were measured. Subjects self-administered (swallowed) oral doses of yohimbine (or placebo) at 11:45am and hydrocortisone (or placebo) at 12:15pm. At 1pm, subjects completed a 60-min neuroimaging scan which included: 1) T1-weighted structural scan, 2) proton functional magnetic resonance spectroscopy (fMRS) acquisition from the left prefrontal cortex during a letter 2-back working memory paradigm, and 3) functional magnetic resonance imaging (fMRI) acquisition during an N-back paradigm yoked with cigarette cues. At 2:30pm, subjects completed an 11-trial choice progressive ratio task in which they could earn cigarette puffs (preferred brand; provided by study) or money. At 3pm, subjects self-administered earned cigarette puffs (video monitored). Subjects remained on site until 4pm discharge.

Conditions

Interventions

TypeNameDescription
DRUGYohimbine Hydrochloride54mg of yohimbine powder was encapsulated in a generic opaque capsule and swallowed with water.
DRUGHydrocortisone10mg hydrocortisone was encapsulated in a generic opaque capsule and swallowed with water.
DRUGLactose Monohydrate PowderLactose powder was encapsulated in generic opaque capsules identical to those used during the acute stress session. Lactose doses weighed the same as the acute stress session doses (54mg and 10mg, respectively).

Timeline

Start date
2016-01-07
Primary completion
2016-10-04
Completion
2016-10-04
First posted
2018-09-13
Last updated
2018-09-13

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03670212. Inclusion in this directory is not an endorsement.