NCT00105482

Brief Summary

Weight gain after quitting smoking is an important barrier to treatment for many smokers. This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

March 5, 2013

Completed
Last Updated

March 5, 2013

Status Verified

January 1, 2013

Enrollment Period

4.2 years

First QC Date

March 14, 2005

Results QC Date

January 28, 2013

Last Update Submit

January 28, 2013

Conditions

Nicotine Dependence

Keywords

TobaccoSmokingWeightWeight perceptionNaltrexone

Outcome Measures

Primary Outcomes (2)

  • Weight Gain at 26 Weeks.

    Weight change from baseline measured at 26 weeks.

    26 weeks

  • Point Prevalence Smoking Abstinence at 26 Weeks.

    The number of people that were abstinent from cigarette smoking at 26 weeks.

    26 weeks

Secondary Outcomes (3)

  • Weight Gain at 6 Weeks.

    6 weeks

  • Point Prevalence Smoking Abstinence at 6 Weeks

    6 weeks

  • Cigarettes Smoked Per Day.

    26 weeks

Study Arms (2)

Naltrexone, Transdermal Nicotine

EXPERIMENTAL

Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day

Drug: NaltrexoneDrug: Transdermal nicotine replacementBehavioral: Behavioral counseling

Placebo Naltrexone, Transdermal Nicotine

PLACEBO COMPARATOR

Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day

Drug: Transdermal nicotine replacementBehavioral: Behavioral counseling

Interventions

NaltrexoneDRUG

Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks

Naltrexone, Transdermal Nicotine
Transdermal nicotine replacementDRUG

Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day

Naltrexone, Transdermal NicotinePlacebo Naltrexone, Transdermal Nicotine
Behavioral counselingBEHAVIORAL

Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.

Naltrexone, Transdermal NicotinePlacebo Naltrexone, Transdermal Nicotine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Concern about gaining weight after quitting. This will be assessed using questionnaires that will provide a rating system to determine qualified participants.
  • \. Age 18 and older.
  • \. Willingness and ability to give written consent.
  • \. Smoking greater than 10 cigarettes per day for at least 1 year.
  • \. At least one prior attempt to stop smoking.
  • \. Baseline expired carbon-monoxide level of at least 10 ppm.
  • \. Weigh at least 100 lbs.
  • \. English speaking.
  • \. One person per household.

You may not qualify if:

  • \. Pregnant or nursing women or women attempting to conceive.
  • \. Unstable cardiac disease.
  • \. History of dermatoses.
  • \. Current alcohol or drug dependence other than nicotine dependence.
  • \. Serious current neurologic, psychiatric or medical illness, including those with a significant risk of committing suicide based on history or investigator's judgment.
  • \. Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist, will make these medications ineffective).
  • \. History of cirrhosis or significant hepatocellular injury as evidenced by SGOT or SGPT \>3 x normal or elevated bilirubin.
  • \. Current use of smokeless tobacco, pipes, cigars, nicotine gum, patch, nasal spray, inhaler, or lozenges.
  • \. Patients requiring concomitant therapy with any psychotropic drug or on any drug with a psychotropic component except those who are on a stable dose of an Selective Serotonin Reuptake Inhibitor for at least two months for the indications of Major Depressive Disorder, Premenstrual Syndrome (PMS) or Premenstrual Dysphoric Disorder (PMDD).
  • \. Subjects with a positive opiate urine drug screen will be excluded to avoid precipitating opiate withdrawal.
  • \. Current use of opiates.
  • \. Currently on a medically prescribed diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine Substance Abuse Treatment Unit

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • Toll BA, White M, Wu R, Meandzija B, Jatlow P, Makuch R, O'Malley SS. Low-dose naltrexone augmentation of nicotine replacement for smoking cessation with reduced weight gain: a randomized trial. Drug Alcohol Depend. 2010 Oct 1;111(3):200-6. doi: 10.1016/j.drugalcdep.2010.04.015. Epub 2010 Jun 12.

    PMID: 20542391RESULT

Related Links

MeSH Terms

Conditions

Tobacco Use DisorderSmokingBody Weight

Interventions

NaltrexoneBehavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Stephanie Samples O'Malley PhD, Director, Division of Substance Abuse Research
Organization
Yale School of Medicine, Department of Psychiatry
stephanie.omalley@yale.edu
(203) 974-7590

Study Officials

  • Stephanie O'Malley, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

March 14, 2005

First Posted

March 15, 2005

Study Start

January 1, 2005

Primary Completion

April 1, 2009

Study Completion

October 1, 2009

Last Updated

March 5, 2013

Results First Posted

March 5, 2013

Record last verified: 2013-01

Locations

US(1)