Effects of Varenicline in Heavy Drinking Smokers

NCT02488889 | Withdrawn Phase 4

• 1 other identifier: 23FT-0102
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This laboratory study will examine if varenicline can reduce alcohol-induced smoking lapse in heavy drinking smokers.

Conditions

Cigarette Smoking; Alcohol Consumption

Keywords

Chantix

Outcome Measures

Primary Outcomes (2)

• The latency to initiate smoking during the delay period. Performance on the smoking lapse task

  In this task, eight cigarettes of the participants' preferred brand are placed in front of them with a lighter and an ashtray. Then, over the next 50 minutes they have the option to initiate a cigarette self-administration session at any point or delay initiation in exchange for monetary reinforcement. Once participants choose to end the delay period in order to smoke or resist smoking for the entire 50-minute delay period, they then participate in a 60-minute cigarette self-administration session, in which they are again given the choice to either smoke their preferred brand of cigarettes or receive monetary reinforcement for cigarettes not smoked. One primary outcome measure from this task is the latency to initiate smoking during the delay period.

  The task will begin five minutes after consumption of the alcohol or placebo beverage and last between 60 and 120 minutes based on performance

• The number of cigarettes smoked during the self-administration period. Performance on the smoking lapse task

  In this task, eight cigarettes of the participants' preferred brand are placed in front of them with a lighter and an ashtray. Then, over the next 50 minutes they have the option to initiate a cigarette self-administration session at any point or delay initiation in exchange for monetary reinforcement. Once participants choose to end the delay period in order to smoke or resist smoking for the entire 50-minute delay period, they then participate in a 60-minute cigarette self-administration session, in which they are again given the choice to either smoke their preferred brand of cigarettes or receive monetary reinforcement for cigarettes not smoked. The second primary outcome measure from this task is the number of cigarettes smoked during the self-administration period.

  The task will begin five minutes after consumption of the alcohol or placebo beverage and last between 60 and 120 minutes based on performance

Secondary Outcomes (4)

• Subjective effects of alcohol as measured by the Biphasic Alcohol Effects Scale (BAES)

  up to 50- minutes of the delay period and 60-minutes of the self-administration session

• Subjective effects of smoking as measured by the Nicotine Reward Scale (NRS)

  up to 50- minutes of the delay period and 60-minutes of the self-administration session

• The Drug Effects Questionnaire (DEQ)

  up to 50- minutes of the delay period and 60-minutes of the self-administration session

• Brief Questionnaire of Smoking Urges (B-QSU)

  up to 50- minutes of the delay period and 60-minutes of the self-administration session

Study Arms (2)

Varenicline vs placebo

ACTIVE COMPARATOR

Participants will be titrated on varenicline as follows: days 1-3, .5 mg per day; days 4-7, .5 mg twice per day, and days 7-12, 1 mg twice per day. Placebo and varenicline pills will be matched in number of pills and packaging of active medications.

Drug: Varenicline; Drug: Placebo pill (for varenicline)

Alcohol beverage vs. placebo beverage

ACTIVE COMPARATOR

During each experimental session, participants will ingest a beverage containing placebo (0.0 g/kg; 1% volume of ethanol as taste mask) or alcohol (0.8 g/kg). The beverage will be administered in clear plastic-lidded cups in 2 equal portions that will be consumed during a 5-minute interval and separated by a 5-minute interim rest. The beverages will contain 190-proof ethanol prepared with water, flavored drink mix, and a sucralose-based sugar substitute. Doses for women will be 85% of those of men to adjust for sex differences in total body water.

Drug: Alcohol; Drug: placebo beverage (for alcohol)

Interventions

Varenicline DRUG

Varenicline vs placebo

Placebo pill (for varenicline) DRUG

Varenicline vs placebo

Alcohol DRUG

Alcohol beverage vs. placebo beverage

placebo beverage (for alcohol) DRUG

Alcohol beverage vs. placebo beverage

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be between the ages of 21 and 55 and provide informed consent;
• Smoke \> 10 cigarettes per day for \> 2 years and have a carbon monoxide (CO) \> 10 ppm;
• Report an interest in quitting smoking in the near future, but currently not in the process of quitting;
• Report current heavy drinking according to NIAAA guidelines (62): for men, \> 14 drinks per week or ≥ 5 drinks per occasion at least once per month over the past 12 months; for women, \> 7 drinks per week or ≥ 4 drinks per occasion at least once per month over the past 12 months;
• Not seeking or receiving treatment for alcohol use;
• No current (last 12 months) diagnosis of substance use disorder for any psychoactive substances other than alcohol and nicotine on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V);
• Negative urine toxicology screen for narcotics, amphetamines, and sedative hypnotics at screening;
• No lifetime history of psychotic disorders, bipolar disorders, or major depression with suicidal ideation;
• No current symptoms of moderate depression or higher, indexed by a score ≥ 20 on the Beck Depression Inventory-II (BDI);
• No serious alcohol withdrawal symptoms as indicated by a score \< 10 on the Clinical Institute Withdrawal Assessment for Alcohol-Revised;
• Not pregnant, nursing, or planning on becoming pregnant in the next month (if female);
• Have no medical condition that may interfere with safe study participation (e.g., unstable cardiac, renal, or liver disease, uncontrolled hypertension or diabetes);
• Within normal limit aspartate transaminase (AST), alanine transaminase (ALT), or gamma-glutamyl transferase (GGT) levels;
• Not currently on prescription medication that contraindicates use of VAR.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Addictions Laboratory

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Alcohol Drinking

Interventions

Varenicline; Ethanol; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Drinking Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Alcohols; Organic Chemicals; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: July 2, 2015
• Study Start: August 1, 2015
• Primary Completion: July 17, 2016
• Study Completion: July 17, 2016
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

US (1)