Status:
COMPLETED
Effects of Naltrexone on Nicotine Reinforcement
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
The study was a within-subject double-blind study of the effects of naltrexone versus placebo on the reinforcing value of nicotine, using a validated cigarette choice paradigm. A key question was whet...
Eligibility Criteria
Inclusion
- Participants must be greater than or equal to 18 years
- Based on the medical history, physical and laboratory examination, female subjects must:
- Agree in consent to practice effective contraception during study, be status post-bilateral tubal litigation or be post-menopausal.
- Not be pregnant, nursing, or planning pregnancy
- Based upon self-report, subjects must smoke greater than or equal to 10 non-menthol cigarettes per day
- 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.
- Following orientation by the research staff, subjects must sign written informed consent and HIPAA form.
Exclusion
- 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.)
- Women who are pregnant, planning a pregnancy, or lactating
- 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).
- Current medical problems for which NTX is contraindicated including: active hepatitis (Liver Function Tests 3 times the Upper Limit of Normal).
- History of opiate dependence (prescription drug or illicit use).
- History of or current Diagnostic and Statistical Manual of Mental Disorders (Version IV) (DSM IV) substance use disorders (abuse or dependence involving alcohol, cocaine, stimulants, or benzodiazepines)
- Diagnosis of bulimia and/or anorexia nervosa in the last year
- Current or past use (with in past 12 months) of any medications containing NTX (e.g., Revia, Trexan), allergy to NTX
- Concomitant medications (e.g., monoamine oxidase inhibitors or benzodiazepines within past 14 days, antipsychotics, antidepressants, theophylline, systemic steroids, over-the-counter stimulants and anorectics)
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00270231
Start Date
March 1 2004
End Date
October 1 2005
Last Update
December 10 2013
Active Locations (1)
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1
Tobacco Use Research Center
Philadelphia, Pennsylvania, United States, 19104