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Effects of Naltrexone on Nicotine Reinforcement

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00270231
First received: December 23, 2005
Last updated: September 6, 2007
Last verified: September 2007
History of Changes
  Purpose

Despite preclinical evidence supporting the role of the endogenous opioid system in the reinforcing effects of nicotine, the efficacy of the opioid antagonist naltrexone (NTX) as a tobacco dependence treatment remains unresolved. Research is needed to identify those smokers for whom NTX will have the strongest beneficial effects on smoking behavior. The proposed research bridges existing knowledge of genetic, pharmacologic, and behavioral responses to nicotine, and translates this knowledge to treatment for tobacco dependence. Our immediate goal is to test whether genetic variation in the mu-opioid receptor gene predicts the effects of naltrexone (NTX) on nicotine reinforcement.


Condition Intervention Phase
Tobacco Dependence
 Drug: Naltrexone
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Pharmacogenetic Investigation of Naltrexone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • choice of nicotine vs. denicotinized cigarettes in the cigarette choice paradigm

Estimated Enrollment: 80
Study Start Date: March 2004
Study Completion Date: October 2005
Detailed Description:

The current study is a within-subject double-blind study of the effects of NTX versus PLA on the reinforcing value of nicotine, using a validated cigarette choice paradigm. Following informed consent, 40 smokers from each genotype group (n=80) will be asked to complete two 4-day study phases interspersed with a 5-7 day washout phase. Each 4-day study phase will include a 3-day drug run-up and monitoring phase, then on the 4th day participants will come to the Biobehavioral Lab (BBL) where they will take their final 50mg of study medication and complete a cigarette choice paradigm (See table 2). Following a washout phase, the 4-day sequence will be repeated with the alternative study medication. The order of study medication will be counterbalanced between subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participants must be >18 years

  2. Based on the medical history, physical and laboratory examination, female subjects must:

    1. Agree in consent to practice effective contraception during study, be status post-bilateral tubal litigation or be post-menopausal.
    2. Not be pregnant, nursing, or planning pregnancy
  3. Based upon self-report, subjects must smoke >10 non-menthol, cigarettes/day
  4. Because the OPRM1 variant is common (25-30%) in persons of European ancestry, but very rare in other ethnic groups (e.g., 2-9% of African Americans) it is not scientifically justified to include members of other ethnic groups. Therefore, only persons of European ancestry will be recruited.

  5. Following orientation by the research staff, subjects must sign written informed consent and HIPAA form.

    -

Exclusion Criteria:

  1. Current diagnosis of kidney disease or history of renal function impairment (unless they have recent kidney function tests (within last 3 months) and approval of their primary physician to participate in the study.)
  2. Women who are pregnant, planning a pregnancy, or lactating
  3. Current alcohol use > 25 standard drinks/week (this is because NTX is used to treat alcohol dependence, and effects of NTX on alcohol consumption in alcohol dependent subjects could have indirect effects on cigarette consumption).
  4. Current medical problems for which NTX is contraindicated including: active hepatitis (LFT's 3X Upper Limit of Normal).
  5. History of opiate dependence (prescription drug or illicit use).
  6. History of or current DSM IV substance use disorders (abuse or dependence involving alcohol, cocaine, or stimulants, benzodiazepines)
  7. Diagnosis of bulimia and/or anorexia nervosa in the last year
  8. Current or past use (with in past 12 months) of any medications containing NTX (e.g., Revia, Trexan), allergy to NTX
  9. Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants and anorectics) -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270231

Locations
United States, Pennsylvania
Tobacco Use Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Caryn Lerman, Ph.D. University of Pennsylvania
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00270231     History of Changes
Other Study ID Numbers: 800810, R01-DA017555-03
Study First Received: December 23, 2005
Last Updated: September 6, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
within-subjects, crossover, laboratory study
Naltrexone vs. Placebo

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013