Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.

Menthol smokers randomized to a test session order and received control menthol (0.0% + tobacco flavor), low menthol (0.5% + tobacco flavor), and high menthol (3.2% + tobacco flavor) by standardized inhalation from an e-cigarette just prior to each nicotine infusion (a single menthol condition for each test session). Within each test session, all three IV nicotine conditions were tested, 1 hour apart, by delivering saline, nicotine at 0.25 mg nicotine/70 kg and nicotine at 0.5 mg nicotine/70 kg, in a random order, just after last inhalation. For each participant, the randomized nicotine infusion sequence was fixed across the three test sessions, each performed at least 24 hours apart.

Menthol-Preferring Smokers

Non-menthol smokers randomized to a test session order and received control menthol (0.0% + tobacco flavor), low menthol (0.5% + tobacco flavor), and high menthol (3.2% + tobacco flavor) by standardized inhalation from an e-cigarette just prior to each nicotine infusion (a single menthol condition for each test session). Within each test session, all three IV nicotine conditions were tested, 1 hour apart, by delivering saline, nicotine at 0.25 mg nicotine/70 kg and nicotine at 0.5 mg nicotine/70 kg, in a random order, just after last inhalation. For each participant, the randomized nicotine infusion sequence was fixed across the three test sessions, each performed at least 24 hours apart.

Non-Menthol-Preferring Smokers

Total

Sex: Female, Male

Region of Enrollment

Ratio of plasma 3'-hydroxycotinine / cotinine at baseline

Nicotine Metabolite Ratio

The Drug Effects Questionnaire (DEQ) is used in studies of acute subjective response (SR) to a variety of substances. The DEQ consists of 11 questions: cooling effect, dislike the sensation, any sensations, feel a drug effect, high, feel stimulated, feel a head rush, like drug effect, dislike any effects, craving a cigarette, and like more of the drug. To calculate the DEQ- 'Good Drug Effects', peak values from post-infusion time points were calculated for the change in the intensity of positive subjective effects as measured with 2 DEQ questions - DEQ question #6 'like drug effect' and DEQ question #11 'would like more of the drug'. Each question was measured on a scale with a minimum score of 0 and a maximum score of 100.The peak values for "like" and " I want more" were averaged to obtain a summary score to represent the feel 'Good Drug Effects' composite factor. DEQ measures were skewed and square root transformations were used. Higher scores indicate more positive effects.

Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.
nicotine: In each of 3 test sessions, subjects in each arm will receive a randomized sequence of three intravenous infusions (30 sec each), one hour apart. The infusions will consist of saline, nicotine (.25 mg / 70kg) and nicotine (0.5 mg / 70 kg). The randomized sequence will remain the same between test sessions for a given subject.
menthol: In each of 3 test sessions, subjects will take 6 inhalations from the study e-cigarette, one inhalation every 15 seconds, of the randomized menthol condition for that test session ust prior to each intravenous infusion. The menthol conditions are: 3.2% menthol, 0

Non-Menthol Preferring Smokers

Drug Effects Questionnaire (DEQ)- 'Good Drug Effects'

Each subject in this arm received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25mg and 0.5mg/70kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session.

Non-Methol Preferring Smokers

Overall Study

Mehmet Sofuoglu, M.D.,Ph.D.

Each subject in this arm received a random sequence of 3 different inhaled menthol conditions (3.2% menthol, 0.5% menthol and tobacco-flavor only (0.0% menthol)) across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition.

Nicotine Dependence

In each of 3 test sessions, subjects in each arm will receive a randomized sequence of three intravenous infusions (30 sec each), one hour apart. The infusions will consist of saline, nicotine (.25 mg / 70kg) and nicotine (0.5 mg / 70 kg). The randomized sequence will remain the same between test sessions for a given subject.

nicotine

In each of 3 test sessions, subjects will take 6 inhalations from the study e-cigarette, one inhalation every 15 seconds, of the randomized menthol condition for that test session ust prior to each intravenous infusion. The menthol conditions are: 3.2% menthol, 0.5% menthol and tobacco-flavor only (0.0% menthol)

menthol

Connecticut VA Healthcare System

VA Connecticut Health Care System

The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users

Menthol's Effects on Nicotine Reinforcement in Smokers

Mehmet Sofuoglu

Professor of Psychiatry

Yale University

National Institute on Drug Abuse (NIDA)

Subjects in each of the 2 arms received a random sequence of 3 different inhaled menthol conditions across 3 test sessions (a single menthol condition for each test session). In each test session, a random order of one saline, and 2 nicotine (0.25 mg and 0.5 mg /70 kg) infusions were given one hour apart, concurrent with the randomized menthol inhalation condition for that test session. The randomized sequence of nicotine infusions was the same for each test session.

70 volunteers were double-blinded, placebo-controlled and randomized into 2 groups (smoking with tea filters or regular filters).

The investigators then recruited 59 volunteers with longer smoking history and stronger desire for quitting smoking for smoking cessation test using the tea filter.

Tobacco Cessation

Ran Tao

Smoking Cessation Effect of Tea Filter Through Inhibition of Nicotine Receptor

Phase 1 Study on Smoking Cessation Effect of Tea Filter

Ran Tao/

General Hospital of Beijing PLA Military Region

Chinese Academy of Sciences

topiramate and contingency reinforcement for urine sample confirming cocaine abstinence

Topiramate and random reinforcement irrespective of cocaine use

Placebo and contingency reinforcement for urine sample confirming cocaine abstinence

topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results

1 Topiramate + CR

Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial

2 Topiramate + NonCR

placebo + NonCR: participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence

4 Placebo + NonCR

Placebo and contingency reinforcement for urine sample confirming cocaine abstinence
Contingency Reinforcement: monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results

3 Placebo + CR

Percentage of cocaine positive urine samples as measured by Preston new use rule (50% reduction in cocaine metabolites from previous urine)

Proportion of Cocaine Positive Urine Samples Per Treatment Condition

Voucher earnings used as a measurement of contigency management (CM) or operate conditioning. Volunteers were rewarded vouchers of escalating monetary value for cocaine abstinence, as indicated by a cocaine negative urine sample. The first cocaine negative urine earned a $2.50 voucher, and the value increased by $1.50 for each subsequent cocaine negative sample. Volunteers were awarded a bonus of $10.00 for every three consecutive cocaine negative urine samples. Urine samples were collected 3 times per week, and vouchers were attainable between Weeks 8 and 20.
Contingency management as a measurement of operant conditioning in which positive reinforcement is applied (in this case vouchers of monetary value) and cocaine abstinence

Voucher Earnings

Dr. Annie Umbricht

topiramate and contingency reinforcement for urine sample confirming cocaine abstinence
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.

Topiramate and random reinforcement irrespective of cocaine use
topiramate: topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.

Cocaine Dependence

topiramate powder 0mg - 150 mg with lactate in blind capsules. Two capsules dispensed daily. One capsule ingested under supervision at the methadone window. One capsule to be ingested at home at bedtime. Participant is expected to return the empty blister pack on the following day.
capsules are administered from week 4 through 25 of the trial

topiramate

monetary reward for self-reported cocaine abstinence confirmed by urine toxicology results

Contingency Reinforcement

participant receives placebo capsules and monetary reinforcers by chance, irrespective of cocaine use or abstinence

placebo + NonCR

Umbricht A∗, DeFulio A, Winstanley EL, Tompkins DA, Peirce J, Mintzer MZ, Strain EC, Bigelow GE (2014) Topiramate for cocaine dependence during methadone maintenance treatment: a randomized controlled trial Drug and Alcohol Dependence 140:92-100

panic disorder/nikotin

The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users

Smoking Cessation Effect of Tea Filter Through Inhibition of Nicotine Receptor

Clinical Trial of Topiramate for Cocaine Addiction

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