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Non-Treatment Study of Factors Affecting Cocaine Drug Choice (CTA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00946660
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : June 5, 2012
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University

Tracking Information
First Submitted Date July 24, 2009
First Posted Date July 27, 2009
Last Update Posted Date June 5, 2012
Study Start Date July 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Treatment Study of Factors Affecting Cocaine Drug Choice
Official Title Human Laboratory Model of Cocaine Treatment: Behavioral Economic Analysis: Study 1
Brief Summary This research deals with behaviors that are part of drug dependence. The purpose is to study how certain factors, including money, the amount of drug available, and the amount of work effort, affect cocaine drug choice. Specifically, we will examine the effects of two issues/factors. The first is how hard individuals are willing to work to obtain a drug; the second is how much drug would individuals choose instead of money, when the amount of probability of money is predictable or unpredictable.
Detailed Description

Outpatient Phase: Participants will be outpatients and must come to the Jefferson Avenue Research Program three times a week (Mon-Wed-Fri). This phase will last two weeks. At each visit participants will be asked to provide a urine sample and to complete questionnaires that ask about substance use.

Inpatient Phase: Participants will live on an inpatient research unit at least 2 consecutive nights and possibly up to 20 consecutive nights. Participants cannot have visitors and will not be allowed to leave the inpatient unit (except with a staff escort) unless they drop out of the study. We will collect daily urine samples to make sure participants are not using any drugs except those in the study.

Participants will take part in multiple trials (up to 11 experimental sessions) where they will be given a standard amount of powder (identified as Drug A or Drug B) to inhale through a straw into their nose. The powder will contain placebo (a powder containing no drug) or different doses of cocaine. We will measure how participants are feeling using questionnaires and we will record vital signs-including breathing rate, blood oxygen level, heart rate, and blood pressure.

Participants will also be asked to perform a 3-hour computer task that allows them to work for Drug A, Drug B, or money. At the end of the computer task participants will receive the amount of drug they earned and a receipt for the amount of money they earned.

To complete the study, a minimum stay of 16 inpatient nights is required. The maximum stay is 20 inpatient nights.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole Blood
Sampling Method Non-Probability Sample
Study Population Cocaine abusing or dependent research volunteers
Condition
  • Cocaine Abuse or Dependence
  • Cocaine Related Disorders
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Greenwald MK, Ledgerwood DM, Lundahl LH, Steinmiller CL. Effect of experimental analogs of contingency management treatment on cocaine seeking behavior. Drug Alcohol Depend. 2014 Jun 1;139:164-8. doi: 10.1016/j.drugalcdep.2014.03.009. Epub 2014 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: July¬†24,¬†2009)
16
Original Estimated Enrollment Same as current
Actual Study Completion Date January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or female volunteers(18-55 years of age).
  • Must meet criteria for Cocaine Abuse or Dependence and wish to participate in research.
  • Positive urine test for cocaine.
  • Candidates must be in good health to be eligible.
  • All candidates must receive routine medical (history and physical) exam with standard laboratory tests (complete blood chemistry, urinalysis, urine pregnancy test for females, tuberculin screening), and 12-lead ECG at the initial screening visit.

Exclusion Criteria:

  • Serious psychiatric illness (e.g. psychosis, bipolar, suicide attempts, major depression that is not substance-induced)
  • Substance use disorder other than cocaine abuse or dependence, nicotine dependence, alcohol abuse, sedative abuse or marijuana abuse.
  • Neurological diseases (e.g. stroke, seizures); cardiovascular problems (e.g. myocardial infarction, angina, systolic BP >160 or <95 mmHg, diastolic BP >95 mmHg, or clinically abnormal ECG); pulmonary diseases (e.g. asthma, TB); systemic diseases (e.g. hepatitis, autoimmune diseases)
  • Cognitive impairment
  • Exposed in past 30 days to medications that would increase study risk (e.g. toxicity to major organ systems, psychotropics, asthma inhalers, or interactions with study drugs)
  • Pregnant (urine HCG), lactating (self-report), or if heterosexually active and not using (self-report) medically approved birth control measures (oral or depot contraceptives, IUD, condom/foam, sterilization, tubal ligation)
  • Seeking treatment or being treated for a substance use disorder.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00946660
Other Study ID Numbers NIDA-DA026861
R01DA026861 ( U.S. NIH Grant/Contract )
DCNBR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mark Greenwald, PhD, Wayne State University
Study Sponsor Wayne State University
Collaborators National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Mark Greenwald, PhD Wayne State University
PRS Account Wayne State University
Verification Date June 2012