NCT00502216

Brief Summary

The purpose of this study is to determine whether the combination of naltrexone (Depade) and varenicline (Chantix) minimizes post-smoking cessation weight gain and how well the combination is tolerated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2007

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

July 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 21, 2010

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

1.9 years

First QC Date

July 13, 2007

Results QC Date

June 3, 2010

Last Update Submit

January 12, 2018

Conditions

SmokingNicotine Dependence

Keywords

TobaccoSmokingWeightNaltrexoneVarenicline

Outcome Measures

Primary Outcomes (1)

  • Weight Gain in Treatment Completers

    baseline and 12 weeks

Secondary Outcomes (2)

  • Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment

    4 weeks

  • Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline

    11 weeks

Study Arms (2)

1

EXPERIMENTAL

Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day

Drug: NaltrexoneDrug: Varenicline

2

PLACEBO COMPARATOR

Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day

Drug: Varenicline

Interventions

NaltrexoneDRUG

Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day

1
VareniclineDRUG

Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day; Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day

Also known as: Chantix
12

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18 and 75
  • Smoking 10 or more cigarettes per day
  • Fewer than 3 months of smoking abstinence in the past year
  • Motivated to stop smoking

You may not qualify if:

  • Current use of opiates, and/or a urine toxicology screen positive for opiates
  • Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)
  • Evidence of significant hepatocellular injury as evidence by AST or ALT \>3 x normal or elevated bilirubin
  • History of cirrhosis
  • Any serious or unstable disease within 6 months
  • Seizure risk
  • Diabetes mellitus requiring insulin or oral hypoglycemic medications
  • Hepatic or renal impairment
  • Use of a monoamine oxidase inhibitor in the prior 14 days
  • Clinically significant cardiovascular disease within 6 months
  • Uncontrolled hypertension
  • Baseline systolic blood pressure higher than 150 mm Hg or diastolic blood pressure higher than 95 mm Hg
  • Severe chronic obstructive pulmonary disease
  • History of cancer (except treated basal cell or squamous cell carcinoma of the skin)
  • History of clinically significant allergic reactions
  • +9 more criteria

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)

  • Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

    PMID: 37142273DERIVED

MeSH Terms

Conditions

SmokingTobacco Use DisorderBody Weight

Interventions

NaltrexoneVarenicline

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersSigns 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 CompoundsBenzazepinesHeterocyclic Compounds, 2-RingQuinoxalines

Results Point of Contact

Title
Benjamin Toll, Ph.D.
Organization
Yale University School of Medicine
benjamin.toll@yale.edu
203-974-5767

Study Officials

  • Benjamin A. Toll, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
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

July 13, 2007

First Posted

July 17, 2007

Study Start

July 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 17, 2018

Results First Posted

September 21, 2010

Record last verified: 2018-01

Locations

US(1)