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Cocaine DependencePhase 2NACNCT00218491

Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1

A Phase 2 study testing N-Acetylcysteine in people with Cocaine Dependence, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Currently, no effective drug treatment exists for cocaine dependence. Glutamate levels are disrupted with long-term cocaine use. N-acetyl cysteine (NAC) is a drug that is metabolized by the body to form cysteine, an active compound that normalizes glutamate levels. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cocaine Dependence
What is being tested?
N-Acetylcysteine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
1 siteUnited States
Study dates
Nov 2005to May 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Meets DSM-IV criteria for cocaine dependence, as determined by a mini-SCID interview
  • Currently dependent on cocaine
  • Seeking treatment for cocaine abuse at the time of study entry
  • Currently uses cocaine by smoking, nasal, or intravenous route of administration.
  • Stable physical and mental health, as judged by an interview and physical examination
  • If female, demonstrates a negative pregnancy test and agrees to use an adequate method of contraception for the duration of the study
  • Lives within a 50 mile radius of the research program center and has reliable transportation

Who cannot join

  • Meets DSM-IV criteria for dependence on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana
  • Physiological dependence on alcohol, which requires medical detoxification
  • History of significant liver, kidney, endocrine, cardiac (e.g., arrhythmia requiring medication, angina pectoris, myocardial infarction), stroke, seizure, neurological, non-drug-related psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders (e.g., homocystinuria)
  • History of an adverse reaction to cocaine, including loss of consciousness, chest pain, psychosis, or seizure
  • History of adverse reaction or hypersensitivity to N-acetyl cystine (NAC), or a similar drug
  • Significant active medical or psychiatric illness that might inhibit the ability to complete the study
Show all 18Show fewer
  • Active high blood pressure, defined as a mean of three sitting blood pressure readings of 145/95 or higher within a 10-day period
  • History of or current asthma
  • Occasional or daily use of albuterol or other beta-agonist inhalers
  • Use of carbamazepine, phenytoin, nitrous oxide, methotrexate, 6 azauridine triacetate, or nitroglycerin within the 2 weeks prior to study entry
  • Use of very large doses of folate, cyanocobalamine (vitamin B12), or pyridoxine (vitamin B6) as prescribed by a health care professional; individuals taking very large doses of these vitamins on a self-initiated basis may enter the study if they are willing to stop use 14 days prior to study entry and to use a standard generic multiple vitamin instead
  • Pregnant or breastfeeding
  • Required by the court to obtain treatment for cocaine dependence
  • Not seeking treatment for cocaine dependence
  • Anticipating elective surgery or hospitalization within 20 weeks of study entry
  • Failure to have a consistent residence for the 4 weeks prior to study entry
  • History of childhood or adult seizures
  • Participated in cocaine treatment (clinical or research) within 30 days of study entry

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: A Controlled Trial of N-Acetylcysteine (NAC) for Cocaine Dependence

Currently, no effective drug treatment exists for cocaine dependence. Glutamate levels are disrupted with long-term cocaine use. N-acetyl cysteine (NAC) is a drug that is metabolized by the body to form cysteine, an active compound that normalizes glutamate levels. The purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine dependent individuals.

Read the detailed description

Currently, no effective pharmacological treatment exists for cocaine dependence. Long-term use of cocaine disrupts normal glutamate levels. If addicts stop using cocaine, glutamate levels drop, which encourages addicts to continue seeking the drug. NAC is a drug that increases intracellular cysteine levels, which in turn leads to normalization of glutamate levels. Currently, NAC is used for the treatment of cystic fibrosis, heart disease, and acetaminophen overdose. Since NAC has the capability of restoring normal glutamate levels, it holds potential as a treatment for cocaine dependence. The purpose of this study is to determine the safety and effectiveness of NAC in treating cocaine dependent individuals. In addition, this study will evaluate cocaine craving and withdrawal symptoms in individuals taking NAC.

Participants in this double-blind, placebo-controlled trial will be randomly assigned to receive either NAC or placebo. All participants will undergo an initial evaluation, which will include a physical examination, an electrocardiogram, blood samples, urine tests, and cue reactivity measures. Participants in the NAC group will receive either 600 mg or 1200 mg of NAC, two times each day for 8 weeks. In addition, all participants will receive cognitive behavioral therapy throughout the study on a weekly basis. Cocaine use will be confirmed by a urine drug screen test, three times each week. Participants will be assessed on a number of biomedical and psychosocial variables known to influence cocaine treatment outcomes. After Week 2, participants will repeat the cue reactivity procedures, which will include measuring a participant's craving response when exposed to conditioned reminders of prior cocaine use.

Being tested
N-Acetylcysteine, Matching Placebo
Keywords
Cocaine Dependence
Medical subject headings
Cocaine-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-AcetylcysteineDrug

    1200mg N-Acetylcysteine

  • N-AcetylcysteineDrug

    2400mg N-Acetylcysteine

  • Matching PlaceboDrug

    Matching Placebo

Study groups in NCT00218491
Study groupRoleWhat they receive
1200mg N-AcetylcysteineExperimental1200mg N-Acetylcysteine
Receives: Drug: N-Acetylcysteine
2400mg N-AcetylcysteineExperimental2400mg N-Acetylcysteine
Receives: Drug: N-Acetylcysteine
Matching PlaceboPlacebo comparatorMatching Placebo
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants That Achieved Study Compliance

    Drug and placebo compliance were measured by urine riboflavin levels. Study compliance was defined as 80% or greater weekly urine riboflavin levels equal to or greater than 1500 ng/ml

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionMay 2010
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00218491
Sponsor's protocol ID
NIDA-19903-1
Other IDs
R01DA019903, R01-19903-1, DPMC
Acronym
NAC
Status last verified
Dec 2018
First submitted
16 Sep 2005
Last updated
15 Jan 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing N-Acetylcysteine in people with Cocaine Dependence, run by Medical University of South Carolina 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 7 inclusion and 18 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 15 Jan 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Number of Participants That Achieved Study Compliance (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00218491.

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 15 Jan 2019.

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