Investigation of Nicotine Seeking Behavior in Current Smokers

NCT03670212 | Completed Phase 1 FDA Drug

• 2 other identifiers: 1501013735F31DA040369
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoking

Keywords

cigarette smoking; acute stress; executive function; craving; nicotine seeking; relapse; excitatory neural activity; glutamate; negative affect

Outcome Measures

Primary Outcomes (1)

• Cigarette puff vs. money choice task

  Participants could earn (via computer mouse 'clicks') money or cigarette puffs (preferred brand; provided by the study) across 11 independent choice trials. At the start of each trial, subjects selected either money or cigarette puffs on a computer screen. After each selection, subjects could earn one unit of that selection by satisfying the computer 'mouse' click requirement. The click requirement increased with each successive unit earned separately for cigarette puffs and money following a progressive ratio schedule (5, 12, 33, 100, 180, 340, 540, 835, 1220, 1660, and 2275 'mouse' clicks; identical schedule for both options and experimental sessions). Units were $0.25 money and 1 cigarette puff. Earned cigarette puffs were smoked at the end of the task and earned money was applied to the subject's study payment. The task was completed between 2:30pm and 3pm for each session.

  30 minutes

Secondary Outcomes (2)

• Letter 2-back task

  12 minutes

• Cigarette-cued letter N-back task

  15 minutes

Other Outcomes (6)

• Minnesota Nicotine Withdrawal Scale

  1 minute; collected five times throughout each experimental session

• Brief Questionnaire of Smoking Urges

  1 minute; collected five times throughout each experimental session

• State-Trait Anxiety Inventory

  1 minute; collected five times throughout each experimental session

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo compound, Lactose Monohydrate Powder, was encapsulated in generic opaque capsules identical to the capsules used in the acute stress session. During the placebo session, two capsules were self-administered (swallowed) by each subject. At 11:45am, subjects self-administered a capsule containing 54mg of lactose. At 12:15pm, subjects self-administered a capsule containing 10mg of lactose.

Drug: Lactose Monohydrate Powder

Acute Stress

EXPERIMENTAL

During the acute stress experimental session, subjects self-administered two generic opaque capsules. At 11:45am, subjects self-administered a capsule containing 54mg of Yohimbine Hydrochloride powder. At 12:15pm, subjects self-administered a capsule containing 10mg of Hydrocortisone.

Drug: Yohimbine Hydrochloride; Drug: Hydrocortisone

Interventions

Yohimbine Hydrochloride DRUG

54mg of yohimbine powder was encapsulated in a generic opaque capsule and swallowed with water.

Also known as: YOH

Acute Stress

Hydrocortisone DRUG

10mg hydrocortisone was encapsulated in a generic opaque capsule and swallowed with water.

Also known as: HYD

Acute Stress

Lactose Monohydrate Powder DRUG

Lactose 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).

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \) Aged between 21-35 years old, 2) current smokers (expired breath carbon monoxide \> 4ppm, self-reported 10+ cigarettes/day, Fagerstrom test for nicotine dependence score \> 3, 3) normal seated and resting vital signs (systolic blood pressure 80-160mmHg, diastolic blood pressure 50-90mmHg, and heart rate 50-90 bpm), and 4) normal or corrected-normal vision.

You may not qualify if:

• \) Abnormal electrocardiogram (reviewed by licensed cardiologist), 2) magnetic resonance imaging contraindications (e.g. metal implants), 3) medical/neurological contraindications (e.g., diabetes or head trauma), 4) pregnancy (urine test; females only), 5) positive urine test result for opioids, cocaine metabolites, benzodiazepines, barbiturates, or amphetamines, 6) psychiatric contraindications (subject met criteria for current Axis 1 disorder \[other than nicotine dependence\] as indicated by computerized MINI-6 screen), and 7) self-reported marijuana and/or alcohol use on 15+ days in the past month.

Sponsors & Collaborators

• Wayne State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (4)

• Cox LS, Tiffany ST, Christen AG. Evaluation of the brief questionnaire of smoking urges (QSU-brief) in laboratory and clinical settings. Nicotine Tob Res. 2001 Feb;3(1):7-16. doi: 10.1080/14622200020032051.

  PMID: 11260806 BACKGROUND

• Spielberger CD. Assessment of state and trait anxiety: Conceptual and methodological issues. Southern Psychologist 2(4): 6-16, 1985.

  BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Hughes JR, Hatsukami D. Signs and symptoms of tobacco withdrawal. Arch Gen Psychiatry. 1986 Mar;43(3):289-94. doi: 10.1001/archpsyc.1986.01800030107013.

  PMID: 3954551 BACKGROUND

MeSH Terms

Conditions

Cigarette Smoking; Recurrence

Interventions

Yohimbine; Hydrocortisone

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Eric A Woodcock, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded study. Subjects, the experimenter, research assistants, and MRI technician did not know if the oral doses were active (acute stress condition) or inert (placebo session).
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Model Details: Double-blind, placebo-controlled, and randomized cross-over study design. Each subject completed both the placebo and acute stress experimental sessions.

Study Record Dates

• First Submitted: September 9, 2018
• First Posted: September 13, 2018
• Study Start: January 7, 2016
• Primary Completion: October 4, 2016
• Study Completion: October 4, 2016
• Last Updated: September 13, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)