Division
HEAL Study
Title
Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine
Short Description
This is a human laboratory clinical pharmacology study to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.
Release Date
Jun 03, 2020
Description

This is a dose escalating, double-blind, placebo-controlled inpatient study in 16 cocaine-experienced volunteers. The subjects will receive atomoxetine 20 mg once daily (q.d.) for 2 days, 40 mg q.d. for 2 days, 80 mg q.d. for 5 days and 100 mg q.d. for 5 days orally or matched placebo. After beginning daily treatment with either atomoxetine or placebo, subjects will receive treatment cocaine infusions of 20 mg and 40 mg i.v. on the two last days of 80 mg and 100 mg atomoxetine dosage levels. Each cocaine infusion will be preceded or followed by saline i.v. infusion in random order; cocaine and saline infusions will be administered 60 minutes apart. The subjects will be discharged 4 days after the last infusion of cocaine (day 17). Subjects will be requested to return for follow-up 2 weeks after the day of discharge.

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Study Data
Study Links
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Case Report Form(s)
Deidentification Notes
Division
HEAL Study
Investigator(s)
Title
Investigating the Impact of Nicotine Using Spectrum Cigarettes (P1S1) - Grant U54-DA031659
Short Description
Study the relationship between very low nicotine cigarettes and cigarette/tobacco use, nicotine/tobacco exposure and dependence, and other health-related behaviors and consequences
Release Date
Feb 14, 2020
Description

Project 1, Study 1 will evaluate the relationship between nicotine yield of very low nicotine content cigarettes and cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cognitive function, cardiovascular function, and perceived risk. We will also consider differences between conditions in compliance with product use.

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Please note that the supplementary documents may not be fully Section 508 compliant. Please contact us for assistance.

Study Data
Study Links
Study Documents

Contemplation Ladder

Submitted by administrator on
Abbreviation
CLADDER
Description

The Contemplation Ladder was designed as a continuous measure of readiness to quit smoking. It is a very brief measure, sensitive to interventions designed to enhance motivation in substance abusers. It consists of the image of a ladder with 11 "rungs" and 5 anchor statements loosely reflecting the stages of change (precontemplation, contemplation, preparation, action, maintenance). Subjects circle the "rung" that most closely matches their level of interest in changing their smoking behavior.

Category
Substance Use
Subcategory
Tobacco

Wisconsin Index of Smoking Dependence Motives

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Abbreviation
WISDM
Description

A multidimensional measure of tobacco dependence and smoking motives, using 68 responses to questions in 13 motivational areas that include emotional attachment to smoking, response to other smokers, smoking to relieve stress, smoking for mental stimulation, and smoking automatically. The Brief WIS-DM is comprised of 37 items that load onto 11 subscales. A study of the Brief WISDM (Smith et al, 2010) found good evidence it can be used in place of the original 68-item version if researchers desire to reduce participant assessment burden.

Category
Substance Use
Subcategory
Tobacco

Short Michigan Alcohol Screening Test

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Abbreviation
SMAST
Description

The Short Michigan Alcoholism Screening Test (SMAST) is comprised of 13 discriminating questions taken from the MAST, which has 25 items. It has been well-validated in primary care settings; evaluation data indicate that it is an effective diagnostis instrument and does not have a tendency to produce false positives, as does the MAST

Category
Substance Use
Subcategory
Alcohol

Drug Abuse Screening Test

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Abbreviation
DAST
Description

A brief instrument for clinical and non-clinical screening to detect drug abuse or dependence disorders. It is most useful in settings in which seeking treatment for drug use problems is not the patient's stated goal. The DAST provides a quantitative index of the severity of problems related to drug abuse other than alcohol.

Category
Substance Use
Subcategory
Drugs

Breath Alcohol

Submitted by administrator on
Abbreviation
EXH-Alc
Description

Expired alcohol level, used to estimate the blood alcohol concentration (BAC)

Category
Substance Use
Subcategory
Alcohol