Phase 2
Completed N=22
Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy
Alcohol Drinking
Source: ClinicalTrials.gov NCT00699556 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Number of Drinks Consumed During an Ad-libitum Drinking Period — 1.59; 1.64 drinks
Summary
This study examines the effect of combined nicotine replacement therapy (transdermal patch + nasal spray vs. transdermal patch + placebo nasal spray) on reactivity to alcohol and self-administration behavior.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Drinks Consumed During an Ad-libitum Drinking Period |
1.59; 1.64 | — |
| SECONDARY Craving for Alcohol |
14.75; 17.03 | — |
Eligibility Criteria
Inclusion Criteria
- Ages 21 and over
- Able to read and write in English
- Smoker
- Heavy drinker
Exclusion Criteria
- Any significant current medical or psychiatric conditions that would contraindicate the consumption of alcohol or nicotine
- Significant hepatocellular injury
- Positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- Women who are pregnant or nursing
- Suicidal, homicidal, or evidence of severe mental illness
- Prescription of any psychotropic drug in the 30 days prior to study enrollment
- Blood donation within the past 8 weeks
- Individuals who are seeking treatment for drinking or smoking who have attempted to quit drinking or smoking within the past 3 months
- Specific exclusions for administration of nicotine nasal spray not specified above including nasal polyps, chronic nasal congestion, allergies, sinusitis
- Specific exclusions for administration of nicotine patch not specified above including history of dermatoses
- Reported sensitivity or allergies to pepper or pepper spray, peppermint, or prior adverse reaction to nicotine spray
- Participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
Data sourced from ClinicalTrials.gov (NCT00699556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.