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

Sponsor
University of Vermont (Other)
Overall Status
Completed
CT.gov ID
NCT02250664
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), Johns Hopkins University (Other)
282
2
3
36
141
3.9

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Other: Very low nicotine content cigarettes
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
282 participants
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
Study Start Date :
Oct 1, 2016
Actual Primary Completion Date :
Oct 1, 2019
Actual Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Cigarettes per day [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

  10. 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.

  11. 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).

  1. Participants failing for blood pressure will be allowed to re-screen once.
  1. Breath CO > 80 ppm.

  2. 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).

  3. Currently seeking treatment for smoking cessation.

  4. Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression).

  5. Current symptoms of psychosis or dementia, or mania.

  6. 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

Locations

Site City State Country Postal Code
1 Johns Hopkins University Baltimore Maryland United States 21224
2 University of Vermont Burlington Vermont United States 05401

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
  • Principal Investigator: Stacey Sigmon, Ph.D., University of Vermont

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stephen T. Higgins, PhD, Professor, University of Vermont
ClinicalTrials.gov Identifier:
NCT02250664
Other Study ID Numbers:
  • P50DA036114:P2S2
  • P50DA036114
First Posted:
Sep 26, 2014
Last Update Posted:
Jun 11, 2020
Last Verified:
Oct 1, 2016
Keywords provided by Stephen T. Higgins, PhD, Professor, University of Vermont
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 11, 2020