Cocaine DependenceEarly Phase 1NCT02994875
Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence
A Early Phase 1 study testing N-acetylcysteine in people with Cocaine Dependence, run by Yale University at 1 site in United States.
Trial summary
The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Sep 2020
- Phase
- Early Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enrollment in the APT methadone program and maintained on a stable dose of methadone for ≥ 2 weeks
- males or females, aged 18-65
- confirmed DSM-IV diagnosis of current cocaine use disorder as assessed at the screening assessment
- for women of a child-bearing age, acceptable birth control method
- ability to commit to 4 weeks of study participation plus 1-month follow-up
- willingness to be randomized to NAC or placebo
- eligibility for MRI scanning and willingness to participate in MRI scanning.
Who cannot join
- Do not meet DSM-IV criteria for cocaine-use disorder.
- Meet DSM-IV psychiatric classifications for lifetime schizophrenia or bipolar disorder, or exhibit significant current suicidal or homicidal plans and intent such that hospitalization is required.
- Meet DSM-IV criteria for current alcohol or other substance-use disorder dependence (with the exceptions of nicotine, cocaine and opioids).
- Have previously taken or currently take NAC.
- Have asthma (due to possible complications with NAC).
- Cannot commit to 4-weeks of study participation or are unwilling to accept randomization.
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- Have any contraindications for MRI scanning (e.g., pregnancy, color-blindness, claustrophobia, metal implants that could interfere with MRI, any other contraindication to scanning).
- Have lab work (complete blood count, urinalysis, liver function tests, thyroid function tests) suggesting the presence of any abnormalities or have a significant or unstable medical illness.
- Are women who are pregnant or of a child-bearing age who do not agree to adequate contraception to prevent pregnancy during the study period.
- Are not fluent in English.
- Do not have at least a 6th grade reading level.
- Cannot provide written, informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence.
Read the detailed description
The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence. Specifically, this application proposes to conduct a randomized, double-blind, placebo-controlled, cross-over pilot study to examine the effects of 7-day NAC administration (2400mg/day) on the neural networks engaged during response inhibition (Go/No-Go task) and affective (emotion-regulation task) processes among cocaine-dependent, methadone-maintained individuals (n=40; 20 per treatment-order condition).
- Conditions
- Cocaine Dependence
- Being tested
- N-acetylcysteine, Placebo
- 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-acetylcysteineDietary supplement
Also called NAC
NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications.
PlaceboOther
Sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Placebo First | Placebo comparator | Placebo - Participants will receive placebo for one week. Following a two-week washout period, they will receive NAC for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications Receives: Other: Placebo |
| NAC First | Active comparator | N-acetylcysteine - Participants will receive NAC for one week. Following a two-week washout period, they will receive placebo for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications Receives: Dietary Supplement: N-acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neural network engagement measured using functional magnetic resonance imaging
The primary outcome measure for this study is change (NAC versus placebo) in neural network engagement during fMRI task performance.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startMay 2016
- Primary completionSep 2020
- Study completionSep 2020
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 DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Sarah Yip, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02994875
- Sponsor's protocol ID
- 1510016617
- Other IDs
- 1K01DA039299-01A1
- Status last verified
- Sep 2020
- First submitted
- 11 Jul 2016
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Birney S, Cheng A, Babuscio T, Dwy S, Orazietti S, Worhunsky PD, Shi J, Sofuoglu M, Constable T, Potenza MN, Carroll K, Yip SW. Neuroimaging as the 'missing link' for preclinical to clinical translation: an example using N-acetylcysteine among individuals with cocaine- and opioid-use disorders receiving methadone treatment. Psychopharmacology (Berl). 2026 May 11. doi: 10.1007/s00213-026-07071-2. Online ahead of print.
PubMed 42108273
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging of N-acetylcysteine in Cocaine Dependence
- ClinicalTrials.gov ID
- NCT02994875
- Acronym / sponsor ID
- 1510016617
- Conditions
- Cocaine Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 16 Dec 2016 (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.
The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence.
Detailed description
The objective of this research is to identify the functional neural mechanisms (as assessed using fMRI) of short-term N-acetylcysteine (NAC) administration among methadone-maintained individuals with cocaine dependence. Specifically, this application proposes to conduct a randomized, double-blind, placebo-controlled, cross-over pilot study to examine the effects of 7-day NAC administration (2400mg/day) on the neural networks engaged during response inhibition (Go/No-Go task) and affective (emotion-regulation task) processes among cocaine-dependent, methadone-maintained individuals (n=40; 20 per treatment-order condition).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo First | Placebo comparator | Other: PlaceboPlacebo - Participants will receive placebo for one week. Following a two-week washout period, they will receive NAC for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications |
| NAC First | Active comparator | Dietary Supplement: N-acetylcysteineN-acetylcysteine - Participants will receive NAC for one week. Following a two-week washout period, they will receive placebo for one week. NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- enrollment in the APT methadone program and maintained on a stable dose of methadone for ≥ 2 weeks
- males or females, aged 18-65
- confirmed DSM-IV diagnosis of current cocaine use disorder as assessed at the screening assessment
- for women of a child-bearing age, acceptable birth control method
- ability to commit to 4 weeks of study participation plus 1-month follow-up
Key exclusion criteria (12 listed)
- Do not meet DSM-IV criteria for cocaine-use disorder.
- Meet DSM-IV psychiatric classifications for lifetime schizophrenia or bipolar disorder, or exhibit significant current suicidal or homicidal plans and intent such that hospitalization is required.
- Meet DSM-IV criteria for current alcohol or other substance-use disorder dependence (with the exceptions of nicotine, cocaine and opioids).
- Have previously taken or currently take NAC.
- Have asthma (due to possible complications with NAC).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteineAlso: NACNAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications. | Dietary supplement | NAC First |
| PlaceboSugar pill | Other | Placebo First |
Primary outcome
Change in neural network engagement measured using functional magnetic resonance imaging
Time frame: 4 weeks
The primary outcome measure for this study is change (NAC versus placebo) in neural network engagement during fMRI task performance.
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 Oct 2020.
- Derived from this study: PubMed 42108273Birney S, Cheng A, Babuscio T, Dwy S, Orazietti S, Worhunsky PD, Shi J, Sofuoglu M, Constable T, Potenza MN, Carroll K, Yip SW. Neuroimaging as the 'missing link' for preclinical to clinical translation: an example using N-acetylcysteine among individuals with cocaine- and opioid-use disorders receiving methadone treatment. Psychopharmacology (Berl). 2026 May 11. doi: 10.1007/s00213-026-07071-2. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
Sarah Yip, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing N-acetylcysteine in people with Cocaine Dependence, run by Yale 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 7 inclusion and 12 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 Oct 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Change in neural network engagement measured using functional magnetic resonance imaging (time frame: 4 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 NCT02994875, 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 Oct 2020.