Efficacy of Naltrexone in Women's Smoking Cessation

NCT00271024 | Completed Phase 2 Results

• 2 other identifiers: 13976A (R01 DA016834)R01DA016834
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the proposed study is to conduct a randomized, double-blind clinical trial to compare adjunct treatment with 50 mg oral naltrexone vs. placebo in conjunction with standard smoking cessation treatment with nicotine patch and counseling. Hypotheses:

1. 1.Naltrexone will improve smoking cessation quit rates, as measured at the end of active treatment (3 months) and during long term follow up (1 year).
2. 2.Weight and smoking-related variables (i.e., less weight gain, as well as reduced craving and withdrawal) will be important factors by which naltrexone improves smoking cessation outcome.
3. 3.These effects are predicted to be stronger in women compared to men.

Conditions

Smoking; Smoking Cessation

Keywords

Smoking; Smoking Cessation

Outcome Measures

Primary Outcomes (6)

• Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date

  Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.

  4 Weeks Following Smoking Quit Date (Study week 7)

• Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date

  Prolonged Abstinence at 12 weeks post quit date (Study Week 15). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.

  12 Weeks Following Smoking Quit Date (Study week 15)

• 7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date

  7-Day Point Prevalence smoking abstinence at 4 weeks post quit date (Study Week 7). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.

  4 Weeks Following Smoking Quit Date (Study week 7)

• 7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date

  7-Day Point Prevalence smoking abstinence at 12 weeks post quit date (Study Week 15). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.

  12 Weeks Following Smoking Quit Date (Study week 15)

• 7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date

  7-Day Point Prevalence smoking abstinence at 29 weeks post quit date (Study Week 29). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.

  26 Weeks Following Smoking Quit Date (Study week 29)

• 7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date

  7-Day Point Prevalence smoking abstinence at 52 weeks post quit date (Study Week 55). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.

  52 Weeks Following Smoking Quit Date (Study week 55)

Secondary Outcomes (4)

• Weight Change at End of Treatment (Smoking Abstinent Only)

  Weight change at 12 weeks post smoking quit date (study week 15)

• Weight Change at End of Treatment (Regardless of Quit Status)

  Weight change at 12 weeks post quit date (study week 15) from smoking quit date

• Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date

  1-Week Post Quit Date (Study Week 4)

• Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date

  4-Weeks Post Quit Date (Study Week 7)

Study Arms (4)

Male Naltrexone

EXPERIMENTAL

50 mg Naltrexone tablet

Drug: Naltrexone (drug)

Female Naltrexone

EXPERIMENTAL

Females receiving either naltrexone (50 mg)

Drug: Naltrexone (drug)

Male Placebo

PLACEBO COMPARATOR

Males receiving Placebo (sugar pill)

Drug: Placebo (for Naltrexone)

Female Placebo

PLACEBO COMPARATOR

Females receiving placebo (sugar pill)

Drug: Placebo (for Naltrexone)

Interventions

Naltrexone (drug) DRUG

50 mg q.d. for 13 weeks

Female Naltrexone; Male Naltrexone

Placebo (for Naltrexone) DRUG

Sugar pill manufactured to mimic Naltrexone tablet

Female Placebo; Male Placebo

Eligibility Criteria

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

You may qualify if:

• Age 18-65, male or female
• Cigarette smoker of at least 15 but no more than 40 cigarettes daily for at least two years
• Current diagnosis of DSM-IV Nicotine Dependence, based on SCID interview

You may not qualify if:

• Desire to quit smoking (self-report rating of interest in quitting at least a 7 on a 10-point scale)
• Nicometer® cotinine level at baseline at least a 5 on a 6-point scale
• Reports not quitting smoking in the past three months for more than one week duration
• Agrees to attend behavioral counseling sessions and complete study measures
• Has stable residence and telephone and can provide the name of an outside household collateral family member or close friend
• Substance Dependence in the last one year (other than DSM-IV Nicotine Dependence) or any history of Opioid Dependence (lifetime)
• Major psychiatric disorder in the last one year, including Axis I disorders or any history of moderate/severe Axis II Disorder, Bipolar Disorder or Psychotic Disorder, based on SCID interview and standard cut-off thresholds on screening questionnaires
• Past or current medical disorders (cardiovascular, hepatic, neurological, endocrine, etc.) which may adversely interact with study measures
• Clinically significant lab test abnormalities, positive urine toxicology, or positive pregnancy test
• Currently pregnant, plans to become pregnant, or lack of effective birth control over next three months, and/or currently lactating, or plans for breastfeeding over next three months
• History of adverse reaction to opioid antagonist or nicotine replacement treatment
• Use of any medication that may adversely interact with study measures (antidepressants, phenothiazines, benzodiazepines, etc.); recent or regular use of an opioid medication
• Unwillingness to attend smoking cessation treatment sessions, take the nicotine patch, or be randomized into medication or placebo conditions, or be available for follow-up assessments
• Unwillingness to agree to DNA analysis.

Sponsors & Collaborators

• University of Chicago: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The University of Chicago, Department of Psychiatry

Chicago, Illinois, 60637, United States

Location

Related Publications (5)

• King AC, Meyer PJ. Naltrexone alteration of acute smoking response in nicotine-dependent subjects. Pharmacol Biochem Behav. 2000 Jul;66(3):563-72. doi: 10.1016/s0091-3057(00)00258-6.

  PMID: 10899371 BACKGROUND

• King AC. Role of naltrexone in initial smoking cessation: preliminary findings. Alcohol Clin Exp Res. 2002 Dec;26(12):1942-4. doi: 10.1097/01.ALC.0000041003.44118.9B. No abstract available.

  PMID: 12500129 BACKGROUND

• Epstein AM, King AC. Naltrexone attenuates acute cigarette smoking behavior. Pharmacol Biochem Behav. 2004 Jan;77(1):29-37. doi: 10.1016/j.pbb.2003.09.017.

  PMID: 14724039 BACKGROUND

• King A, de Wit H, Riley RC, Cao D, Niaura R, Hatsukami D. Efficacy of naltrexone in smoking cessation: a preliminary study and an examination of sex differences. Nicotine Tob Res. 2006 Oct;8(5):671-82. doi: 10.1080/14622200600789767.

  PMID: 17008194 BACKGROUND

• King AC, Cao D, Zhang L, O'Malley SS. Naltrexone reduction of long-term smoking cessation weight gain in women but not men: a randomized controlled trial. Biol Psychiatry. 2013 May 1;73(9):924-30. doi: 10.1016/j.biopsych.2012.09.025. Epub 2012 Nov 22.

  PMID: 23177384 DERIVED

Related Links

• Main Study Website

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Naltrexone; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Andrea King
• Organization: University of Chicago

aking@bsdad.uchicago.edu

7737026181

Study Officials

• Andrea C King, PhD

  The University of Chicago, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2005
• First Posted: December 29, 2005
• Study Start: December 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: March 1, 2010
• Last Updated: March 23, 2023
• Results First Posted: April 26, 2013

Record last verified: 2023-02

Locations

US (1)