Cocaine Abuse or DependenceCTANCT00946660
Non-Treatment Study of Factors Affecting Cocaine Drug Choice
An observational study of Cocaine Abuse or Dependence and Cocaine Related Disorders, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cocaine Abuse or Dependence, Cocaine Related Disorders
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Cocaine abusing or dependent research volunteers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Laboratory Model of Cocaine Treatment: Behavioral Economic Analysis: Study 1
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.
Read the 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.
- Keywords
- Contingency Management, Drug Self-Administration
- Medical subject headings
- Cocaine-Related Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cocaine Abuse or DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mark Greenwald, PhD, Wayne State University
- Investigators
- Mark Greenwald, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946660
- Sponsor's protocol ID
- NIDA-DA026861
- Other IDs
- R01DA026861, DCNBR
- Acronym
- CTA
- Status last verified
- Jun 2012
- First submitted
- 24 Jul 2009
- Last updated
- 5 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 24685561
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Laboratory Model of Cocaine Treatment: Behavioral Economic Analysis: Study 1
- ClinicalTrials.gov ID
- NCT00946660
- Acronym / sponsor ID
- CTA / NIDA-DA026861
- Keywords
- Contingency Management, Drug Self-Administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Cocaine abusing or dependent research volunteers
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2012.
- Derived from this study: PubMed 24685561Greenwald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Greenwald, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cocaine Abuse or Dependence and Cocaine Related Disorders, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2012.