Cannabis DependencePhase 1/2NAC MJ PilotNCT00542750
An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents
A Phase 1/2 study testing N-Acetylcysteine in people with Cannabis Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Cannabis Dependence
- What is being tested?
- N-Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2008
- Phase
- Phase 1/2
- 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 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female, 12 - 20 years old.
- Participants must be regular smokers of marijuana (on average smoke at least 3 times per week for at least one year) and meet DSM-IV Criteria for cannabis dependence, with desire to cut down on marijuana use.
- Participants must understand all oral and written informed consent and give such consent prior to on-site screening.
- Participants must agree to refrain from marijuana use for 24 hours prior to each cue reactivity session (Visits 2 and 4).
- Participants must have a person that can be contacted in case of emergency.
- Participants must have had stable residence for the past 30 days.
- Post-menarchal female participants must agree to use birth control to avoid pregnancy.
Who cannot join
- Allergy or intolerance to N-Acetylcysteine (NAC).
- Pregnancy or lactation.
- History of seizures.
- Current or past history of asthma and/or the occasional or daily use of albuterol or other beta-agonist inhalers.
- Current use of medications that might affect heart rate or skin conductance.
- Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study.
- History of significant hepatic, renal, endocrine, cardiac (i.e., arrhythmia requiring medication, angina pectoris, myocardial infarction,), stroke, seizure, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, metabolic, or other disorders that may place the participant at increased risk per the judgment of the study physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.
Read the detailed description
This project involves investigation of oral N-acetylcysteine (NAC) as a potential pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence continues to be a major problem among adolescents in the United States. To date, psychosocial interventions have produced only small to modest effect sizes in controlled trials, and minimal work has been done to investigate the potential role for pharmacotherapy for cannabis dependence. Translating preclinical research suggesting a role for NAC in cocaine dependent individuals, our research group has developed preliminary evidence of decreased cocaine use and cue reactivity in humans taking NAC. Preclinical research has additionally demonstrated significant parallels in glutamatergic dysfunction in the nucleus accumbens (the proposed target of NAC treatment) between habitual cocaine and marijuana users. NAC is an inexpensive, long-available agent with a favorable tolerability profile in adults and children. However, it has not yet been studied in cannabis dependent adolescents. Hence, we are undertaking an open-label pilot trial of NAC in adolescents with cannabis dependence.
The primary specific aims of the proposed project are:
- To assess the feasibility of conducting a trial of NAC in cannabis dependent adolescents.
- To assess the safety and tolerability of NAC in cannabis dependent adolescents The secondary specific aim of the proposed project is:
- To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
Primary hypotheses
- It will be feasible to recruit and retain cannabis dependent adolescents in a trial of NAC.
- NAC will be well tolerated among cannabis dependent adolescents. Secondary hypothesis
- Adequate variability information will be gathered to design a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
Twenty-four adolescents between 12 and 20 years old will be recruited in this study. Results from this project will be used to design further studies.
- Conditions
- Cannabis Dependence
- Being tested
- N-Acetylcysteine
- Keywords
- Cannabis, Marijuana, Pharmacotherapy, Adolescent
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDrug
Also called GNC brand USP-grade NAC (600 mg capsules)
N-Acetylcysteine 1200 mg twice daily for four weeks
| Study group | Role | What they receive |
|---|---|---|
| N-Acetylcysteine | Experimental | All participants will receive N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues will be investigated. Receives: Drug: N-Acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period
Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cannabis DependenceStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), American Academy of Child Adolescent Psychiatry.
- Responsible party
- Principal investigator, Kevin Gray, MD, Medical University of South Carolina
- Investigators
- Kevin M Gray, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542750
- Sponsor's protocol ID
- 5K12 DA 000357 NAC MJ Pilot
- Other IDs
- K12DA000357
- Acronym
- NAC MJ Pilot
- Status last verified
- Apr 2018
- First submitted
- 10 Oct 2007
- Last updated
- 23 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial of N-Acetylcysteine in Cannabis Dependent Adolescents
- ClinicalTrials.gov ID
- NCT00542750
- Acronym / sponsor ID
- NAC MJ Pilot / 5K12 DA 000357 NAC MJ Pilot
- Conditions
- Cannabis Dependence
- Keywords
- Cannabis, Marijuana, Pharmacotherapy, Adolescent
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), American Academy of Child Adolescent Psychiatry.
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Posted 23 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to determine the feasibility of conducting a trial of N-Acetylcysteine in cannabis dependent adolescents.
Detailed description
This project involves investigation of oral N-acetylcysteine (NAC) as a potential pharmacologic agent for treatment of cannabis dependence in adolescents. Cannabis dependence continues to be a major problem among adolescents in the United States. To date, psychosocial interventions have produced only small to modest effect sizes in controlled trials, and minimal work has been done to investigate the potential role for pharmacotherapy for cannabis dependence. Translating preclinical research suggesting a role for NAC in cocaine dependent individuals, our research group has developed preliminary evidence of decreased cocaine use and cue reactivity in humans taking NAC. Preclinical research has additionally demonstrated significant parallels in glutamatergic dysfunction in the nucleus accumbens (the proposed target of NAC treatment) between habitual cocaine and marijuana users. NAC is an inexpensive, long-available agent with a favorable tolerability profile in adults and children. However, it has not yet been studied in cannabis dependent adolescents. Hence, we are undertaking an open-label pilot trial of NAC in adolescents with cannabis dependence.
The primary specific aims of the proposed project are:
- To assess the feasibility of conducting a trial of NAC in cannabis dependent adolescents.
- To assess the safety and tolerability of NAC in cannabis dependent adolescents The secondary specific aim of the proposed project is:
- To gather variability information to assist in design of a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
Primary hypotheses
- It will be feasible to recruit and retain cannabis dependent adolescents in a trial of NAC.
- NAC will be well tolerated among cannabis dependent adolescents. Secondary hypothesis
- Adequate variability information will be gathered to design a larger-scale, adequately powered clinical trial of NAC in cannabis dependent adolescents.
Twenty-four adolescents between 12 and 20 years old will be recruited in this study. Results from this project will be used to design further studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| N-Acetylcysteine | Experimental | Drug: N-AcetylcysteineAll participants will receive N-Acetylcysteine 1200 mg twice daily during four weeks of participation. Tolerability, marijuana use, and reactivity to marijuana cues will be investigated. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Male or female, 12 - 20 years old.
- Participants must be regular smokers of marijuana (on average smoke at least 3 times per week for at least one year) and meet DSM-IV Criteria for cannabis dependence, with desire to cut down on marijuana use.
- Participants must understand all oral and written informed consent and give such consent prior to on-site screening.
- Participants must agree to refrain from marijuana use for 24 hours prior to each cue reactivity session (Visits 2 and 4).
- Participants must have a person that can be contacted in case of emergency.
Key exclusion criteria (7 listed)
- Allergy or intolerance to N-Acetylcysteine (NAC).
- Pregnancy or lactation.
- History of seizures.
- Current or past history of asthma and/or the occasional or daily use of albuterol or other beta-agonist inhalers.
- Current use of medications that might affect heart rate or skin conductance.
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: GNC brand USP-grade NAC (600 mg capsules)N-Acetylcysteine 1200 mg twice daily for four weeks | Drug | N-Acetylcysteine |
Primary outcome
Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period
Time frame: one year
Feasibility of recruiting and retaining participants during the study period. This is the primary outcome of interest for this proof-of-concept feasibility preliminary study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kevin M Gray, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing N-Acetylcysteine in people with Cannabis 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 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 23 May 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 23 May 2018). 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?
Feasibility of Recruitment, Measured by Number of Participants Recruited and Retained During Study Period (time frame: one year). It is what the study was designed to measure, not a finding.
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 23 May 2018.