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Trial record 8 of 32 for:    very low nicotine

Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers (P2S2)

This study is currently recruiting participants.
Verified October 2016 by Stephen T. Higgins, University of Vermont
Sponsor:
ClinicalTrials.gov Identifier:
NCT02250664
First Posted: September 26, 2014
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Information provided by (Responsible Party):
Stephen T. Higgins, University of Vermont
  Purpose
This study will examine extended exposure to cigarettes varying in nicotine content among opioid abusers. Prevalence of smoking among opioid-dependent adults far exceeds that of the general US adult population. Opioid-dependent smokers are also at elevated risk for smoking-related adverse health effects. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like opioid abusers who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap.

Condition Intervention Phase
Tobacco Use Disorder Other: Very low nicotine content cigarettes Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Project 2, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Opioid Abusers

Resource links provided by NLM:


Further study details as provided by Stephen T. Higgins, University of Vermont:

Primary Outcome Measures:
  • Cigarettes per day [ Time Frame: 12 weeks ]

Estimated Enrollment: 282
Study Start Date: October 2016
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.8 mg nicotine
0.8 mg nicotine very low nicotine content cigarettes
Other: Very low nicotine content cigarettes
Very low nicotine content cigarettes
Experimental: 0.12 mg nicotine
0.12 mg nicotine very low nicotine content cigarettes
Other: Very low nicotine content cigarettes
Very low nicotine content cigarettes
Experimental: 0.03 mg nicotine
0.03 mg nicotine very low nicotine content cigarettes
Other: Very low nicotine content cigarettes
Very low nicotine content cigarettes

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Men and women ages 18-70, who are currently receiving methadone or buprenorphine maintenance treatment for opioid dependence.
  2. Report smoking ≥ 5 cigarettes per day.
  3. Provide an intake breath CO sample >8 ppm.
  4. Be without current (within the past year) serious mental disorder that would interfere with study results or completion as determined by the licensed medical professional or PI.
  5. Be sufficiently literate to complete the research-related tasks.
  6. Be in good physical health without serious illness or change in health or medication (not including methadone or buprenorphine dose) in the past three months as determined by the license medical professional at each site.
  7. Not pregnant or nursing, and report using oral, implant, injection or barrier contraceptives, or report being surgically sterile, or post menopausal.
  8. Report no significant use of other tobacco or nicotine products within the past month (more than 9 days in the past 30).
  9. Participants must be maintained on a stable methadone or buprenorphine dose for the past month, with no evidence of regular illicit-drug abuse (<30% positive specimens in the past 30 days).

    1. Consent to confirm dose and drug abstinence with the participant's opioid clinic will be obtained at screening and we will monitor any changes in dose throughout the study.
    2. Participants must provide at least three urine samples within the last 30 days. If they do not have three they will be asked to come in and provide a sample. They may leave up to two samples per week with at least one full day between samples.

Exclusion Criteria:

  1. Any prior regular use (used as primary cigarette outside of laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content).
  2. Exclusive use of roll-your-own cigarettes.
  3. Planning to quit smoking in the next 30 days.
  4. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence.
  5. Currently taking anticonvulsant medications.
  6. Positive toxicology screen for illicit drugs not including Marijuana ( participants with valid prescriptions will not be excluded and participants with a positive toxicology screen will be allowed to re-screen once).
  7. Not currently enrolled in a treatment program for opioid dependence and/or not currently stable on their methadone or buprenorphine dose.
  8. Breath alcohol level > 0.01 ( participants with a positive screen will be allowed to re-screen once).
  9. Self-report of binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period in females/males),
  10. Blood pressure is greater than or equal to 160/100 mmHg or below 90/50 mmHg (participants outside the range will be allowed to re-screen once).

    a. Participants failing for blood pressure will be allowed to re-screen once.

  11. Breath CO > 80 ppm.
  12. Heart rate is greater than or equal to 115 bpm or less than 45 bpm ( participants outside the range will be allowed to re-screen once).
  13. Currently seeking treatment for smoking cessation.
  14. Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression).
  15. Current symptoms of psychosis or dementia, or mania.
  16. Suicidal ideation in the past month. 17.) Suicide attempt in the past 6 months. 18.) Participation in another research study in the past 30 days.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250664


Contacts
Contact: Lauren Tursi, BA 802-656-8859 Lauren.Tursi@uvm.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Maxine L. Stitzer, Ph.D.         
Contact: Ryan Vandrey, Ph.D.         
Principal Investigator: Maxine L. Stitzer, Ph.D.         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Principal Investigator: Stacey C. Sigmon, Ph.D.         
Sponsors and Collaborators
University of Vermont
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Investigators
Study Director: Stephen T. Higgins, Ph.D. University of Vermont
  More Information

Responsible Party: Stephen T. Higgins, Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT02250664     History of Changes
Other Study ID Numbers: P50DA036114:P2S2
P50DA036114 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 2014
First Posted: September 26, 2014
Last Update Posted: October 6, 2016
Last Verified: October 2016

Keywords provided by Stephen T. Higgins, University of Vermont:
Biomarkers of exposure
Compensatory smoking
Nicotine dependence
Reduced nicotine cigarettes
Tobacco withdrawal
Women
Health disparities
Vulnerable populations

Additional relevant MeSH terms:
Nicotine
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action