Control Systems Approach to Predicting Individualized Dynamics of Nicotine Cravings

NCT02643914 | Unknown

• 1 other identifier: 1R21DA038467-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Nicotine is the most common drug of abuse in the United States, and has addiction strength comparable to cocaine, heroin, and alcohol. It is the primary addictive component of tobacco, and its use markedly increases risk for cancer, heart disease, asthma, miscarriage, and infant mortality. Addiction is thought to be caused primarily by the intersection of two components: 1) the impact of drug pharmacokinetics on the dynamics of dopamine response, and 2) dysregulation of the brain's reward circuit. While the term 'dysregulated' tends to be used qualitatively within the neuroscience literature, regulation has a precise and testable meaning in control systems engineering, which has yet to be addressed in a quantitative manner by current neuroimaging methods or models of addiction. Current approaches to neuroimaging have primarily focused on identifying nodes and causal connections within the meso-circuit of interest, but have yet to take the next step in treating these nodes and connection as a self-interacting dynamical system evolving over time. Such an approach is critical for improving our understanding, and therefore prediction, of trajectories for addiction as well as recovery.

Conditions

Nicotine Addiction; Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Autonomic nervous system activity will be measured by analysis of heart rate variability and electric dermal activity alongside a 0-10 craving scale.

  through study completion, an average of 1 year

Study Arms (1)

Nicotine Cravings

EXPERIMENTAL

Drug: Nicotine; Device: MR Compatible Nicotine Delivery Device

Interventions

Nicotine DRUG

Also known as: Nicotrol NS

Nicotine Cravings

MR Compatible Nicotine Delivery Device DEVICE

Nicotine Cravings

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Moderate to severe addiction to smoking/nicotine
• Willingness to withdraw from nicotine for 12 hours prior to testing
• Eyesight correctable to 20/20 with contact lenses.

You may not qualify if:

• Electrical implants such as cardiac pacemakers or perfusion pumps
• Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, facial tattoos, or steel implants
• Claustrophobia
• Pregnancy or breastfeeding (for females, pregnancy status will be confirmed with urine test)
• Chronic nasal congestion, sinusitis, or common cold Use of nicotine cessation therapy (patch, gum, inhaler, nasal spray)
• History of asthma, cardiovascular or peripheral vascular disease (anginas, arrhythmias, myocardial infarction, Raynaud's disease, insulin dependent diabetes)
• History of neurological disease (brain tumor, stroke, traumatic brain injury, epilepsy)
• Current use of psychotropic medication

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Bioengineering Building , Stony Brook University

Stony Brook, New York, 11794, United States

Location

Related Publications (6)

• Koob GF, Volkow ND. Neurocircuitry of addiction. Neuropsychopharmacology. 2010 Jan;35(1):217-38. doi: 10.1038/npp.2009.110.

  PMID: 19710631 BACKGROUND

• Koob GF. Addiction is a Reward Deficit and Stress Surfeit Disorder. Front Psychiatry. 2013 Aug 1;4:72. doi: 10.3389/fpsyt.2013.00072. eCollection 2013.

  PMID: 23914176 BACKGROUND

• Volkow ND, Fowler JS, Wang GJ. The addicted human brain viewed in the light of imaging studies: brain circuits and treatment strategies. Neuropharmacology. 2004;47 Suppl 1:3-13. doi: 10.1016/j.neuropharm.2004.07.019.

  PMID: 15464121 BACKGROUND

• Fagerstrom KO. Measuring degree of physical dependence to tobacco smoking with reference to individualization of treatment. Addict Behav. 1978;3(3-4):235-41. doi: 10.1016/0306-4603(78)90024-2. No abstract available.

  PMID: 735910 BACKGROUND

• Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

  PMID: 1932883 BACKGROUND

• Mujica-Parodi LR, Strey HH, Frederick B, Savoy R, Cox D, Botanov Y, Tolkunov D, Rubin D, Weber J. Chemosensory cues to conspecific emotional stress activate amygdala in humans. PLoS One. 2009 Jul 29;4(7):e6415. doi: 10.1371/journal.pone.0006415.

  PMID: 19641623 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Cigarette Smoking

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Lilianne Mujica-Parodi, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Biomedical Engineering

Study Record Dates

• First Submitted: November 24, 2015
• First Posted: December 31, 2015
• Study Start: September 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 2, 2017

Record last verified: 2017-06

Locations

US (1)