Cocaine Abuse or DependenceNACNCT01392092
Effects of N-acetylcysteine on Brain Chemistry and Behavior in Cocaine Abusers (NAC)
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
N-acetylcysteine (NAC) is a medication that the Food and Drug Administration (FDA) has approved for several medical uses, such as dissolving mucus in patients with breathing problems, treating overdose from acetaminophen (Tylenol), and protecting the kidneys from toxic substances. 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 2011to Jun 2017
- 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 and female volunteers (18-55 years of age)
- Must meet DSM-IV criteria for current 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.
- Metal objects in body (e.g. metal plates, part of a bullet from a gunshot wound, or a catheter).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of N-acetylcysteine on Brain Chemistry and Behavior in Cocaine Abusers
N-acetylcysteine (NAC) is a medication that the Food and Drug Administration (FDA) has approved for several medical uses, such as dissolving mucus in patients with breathing problems, treating overdose from acetaminophen (Tylenol), and protecting the kidneys from toxic substances.
Some recent studies suggest that NAC could be useful in the treatment of other disorders including addictions. One purpose of this study is to determine whether NAC alters the level of brain glutamate (a chemical that excites brain cells). The other main purpose is to determine whether NAC affects how much cocaine people use.
Read the detailed description
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. In addition, each morning, afternoon and evening participants will receive a capsule containing placebo (a blank) or different doses of N-acetylcysteine.
Participants will take part in multiple trials (up to 9 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.
On each Monday of the inpatient stay, participants will be escorted to Harper Hospital for a special type of magnetic resonance imaging (MRI) scan, known as magnetic resonance spectroscopy (MRS). This is a non-invasive way to study brain chemistry. Participants will take part in a total of two (2) MRI scans. The total length of each brain scan will be about 2 hours.
Additionally on each Monday of the inpatient stay we will test the sensitivity of the participants brain to magnetic stimulation. A small magnet will be placed on top of the head so that a small electrical current is generated inside the brain. This procedure is called transcranial magnetic stimulation (TMS). We will stimulate the part of the brain that controls finger movement. Three recording electrodes (metal sensors like those used for EKG) will be placed on the right thumb and index fingers. We will measure the effects of different amounts of magnetic stimulation on the muscle activity of the thumb and index fingers (as seen on a computer screen). We will also ask participants to push a lever with their finger during parts of the procedure. These tasks will last about 2 hours.
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 posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- 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
- NCT01392092
- Sponsor's protocol ID
- NAC-1
- Acronym
- NAC
- Status last verified
- Apr 2018
- First submitted
- 11 Jul 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of N-acetylcysteine on Brain Chemistry and Behavior in Cocaine Abusers
- ClinicalTrials.gov ID
- NCT01392092
- Acronym / sponsor ID
- NAC / NAC-1
- Keywords
- Contingency Management, Drug Self-Administration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Jul 2011 (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.
N-acetylcysteine (NAC) is a medication that the Food and Drug Administration (FDA) has approved for several medical uses, such as dissolving mucus in patients with breathing problems, treating overdose from acetaminophen (Tylenol), and protecting the kidneys from toxic substances.
Some recent studies suggest that NAC could be useful in the treatment of other disorders including addictions. One purpose of this study is to determine whether NAC alters the level of brain glutamate (a chemical that excites brain cells). The other main purpose is to determine whether NAC affects how much cocaine people use.
Detailed description
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. In addition, each morning, afternoon and evening participants will receive a capsule containing placebo (a blank) or different doses of N-acetylcysteine.
Participants will take part in multiple trials (up to 9 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.
On each Monday of the inpatient stay, participants will be escorted to Harper Hospital for a special type of magnetic resonance imaging (MRI) scan, known as magnetic resonance spectroscopy (MRS). This is a non-invasive way to study brain chemistry. Participants will take part in a total of two (2) MRI scans. The total length of each brain scan will be about 2 hours.
Additionally on each Monday of the inpatient stay we will test the sensitivity of the participants brain to magnetic stimulation. A small magnet will be placed on top of the head so that a small electrical current is generated inside the brain. This procedure is called transcranial magnetic stimulation (TMS). We will stimulate the part of the brain that controls finger movement. Three recording electrodes (metal sensors like those used for EKG) will be placed on the right thumb and index fingers. We will measure the effects of different amounts of magnetic stimulation on the muscle activity of the thumb and index fingers (as seen on a computer screen). We will also ask participants to push a lever with their finger during parts of the procedure. These tasks will last about 2 hours.
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 and female volunteers (18-55 years of age)
- Must meet DSM-IV criteria for current 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 (8 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 Apr 2018.
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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 8 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 Apr 2018. 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?
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 Apr 2018.