CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Naltrexone +1 moredrug
Likely dose
Bupropion 150 mg SR once daily for 3 days, then twice daily for 7 weeks; Naltrexone 12.5 mg initial dose, then 25 mg daily starting day 6 of bupropion for 7 weeksAI-extracted
Key inclusion· 7
  • ✓Age 18 years or older
  • ✓Currently smoking at least 10 cigarettes per day for at least 1 year
  • ✓Baseline expired carbon monoxide level at least 10 ppm
  • ✓Body weight at least 100 lbs
Key exclusion· 15
  • ✕Pregnant, nursing, or attempting to conceive
  • ✕Serious current neurologic, psychiatric, or medical illness including unstable cardiac, hepatic, or renal disease, diabetes, or hypertension
  • ✕Current alcohol dependence
  • ✕Current opioid use or positive urine toxicology for opiates

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00129246
NCT00129246Phase 2Completed
CompareCT.gov

Naltrexone & Bupropion to Stop Smoking With Less Weight Gain

Yale University·interventional·Posted Aug 11, 2005·Updated Dec 3, 2020

In Brief

A Phase 2 clinical trial evaluating Naltrexone and Bupropion for Smoking and Nicotine Dependence. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmoking, Nicotine Dependence
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 11, 2005
Enrollment StartDec 1, 2004
Study CompletionDec 1, 2005
TodayJul 2, 2026
Posted 20.9 years ago

Interventions

Naltrexonedrug

Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.

Bupropiondrug

Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.