Pathological GamblingPhase 1NCT00273702
An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
A Phase 1 study testing N-Acetyl Cysteine in people with Pathological Gambling, run by University of Minnesota at 1 site in United States.
Trial summary
After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine 600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day at visit 6 unless clinical improvement has been attained at a lower dose (clinical improvement will be assessed by the investigator… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- N-Acetyl Cysteine
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2006
- Phase
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women age 18-65
- Current DSM-IV PG
Who cannot join
- Unstable medical illness on physical examination
- History of seizures
- Myocardial infarction within 6 months
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Clinically significant suicidality
- Lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder
Show all 10Show fewer
- Current or recent (past 3 months) DSM-IV substance abuse or dependence
- Illegal substance within 2 weeks of study initiation
- Initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline
- Previous treatment with N-Acetyl Cysteine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine 600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day at visit 6 unless clinical improvement has been attained at a lower dose (clinical improvement will be assessed by the investigator with respect to gambling thoughts, urges and behavior). If it is clinically necessary to modify this schedule (e.g., because of side effects or an adequate response to a lower dose), the dose will be raised more slowly or the target dose will not be reached.
Subjects will start no other psychotropic medications during the study but may continue on previously prescribed psychotropic medications if on a stable dose for 3 months prior to study entry. Psychotherapy of any form (including cognitive-behavioral therapy) will not be initiated during the study but subjects may continue with current psychotherapy if they have been undergoing therapy for at least three months prior to study entry.
Subjects will be evaluated with the PG-YBOCS, G-SAS, CGI, HAM-D, HAM-A and the Sheehan Disability Inventory at screening and at each visit for the remainder of the study. Medication side effects will be evaluated at each study visit. A tablet count will be kept for each dose of medication taken.
Read the detailed description
Before beginning N-Acetyl Cysteine, all subjects will receive a psychiatric, medical, and family history evaluation as well as the Structured Clinical Interview for DSM-IV (SCID-P) for Axis I disorders. At the screening visit, patients will also receive standard laboratory tests (including ß-HCG), and a physical examination.
The following instruments will be completed at the screening visit and periodically throughout the study: 1) Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS), a reliable and valid semi-structured clinician-administered scale that assesses current severity of PG; 2) Gambling Symptom Assessment Scale (G-SAS), a reliable and valid self-report measure of gambling symptoms; 3) the 17-item Hamilton Rating Scale for Depression (HAM-D); 4) the 17-item Hamilton Rating Scale for Anxiety (HAM-A); 5) Clinical Global Impression scale; 6) the Sheehan Disability Inventory; and 7) the Quality of Life Inventory. Safety evaluations, including pulse and blood pressure, and assessment of side effects will be done at each visit.
After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine 600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day at visit 6 unless clinical improvement has been attained at a lower dose (clinical improvement will be assessed by the investigator with respect to gambling thoughts, urges and behavior). If it is clinically necessary to modify this schedule (e.g., because of side effects or an adequate response to a lower dose), the dose will be raised more slowly or the target dose will not be reached.
Subjects will start no other psychotropic medications during the study but may continue on previously prescribed psychotropic medications if on a stable dose for 3 months prior to study entry. Psychotherapy of any form (including cognitive-behavioral therapy) will not be initiated during the study but subjects may continue with current psychotherapy if they have been undergoing therapy for at least three months prior to study entry.
Subjects will be evaluated with the PG-YBOCS, G-SAS, CGI, HAM-D, HAM-A and the Sheehan Disability Inventory at screening and at each visit for the remainder of the study. Medication side effects will be evaluated at each study visit. A tablet count will be kept for each dose of medication taken.
- Conditions
- Pathological Gambling
- Being tested
- N-Acetyl Cysteine
- Keywords
- Gambling, Gambler, Gamble, Pathological
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl CysteineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
PG-YBOCS
Secondary outcomes (1)
G-SAS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJan 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Investigators
- Jon E Grant, MD, JD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273702
- Sponsor's protocol ID
- 0511M77412
- Status last verified
- Apr 2007
- First submitted
- 6 Jan 2006
- Last updated
- 30 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of N-Acetyl Cysteine in Pathological Gambling
- ClinicalTrials.gov ID
- NCT00273702
- Acronym / sponsor ID
- 0511M77412
- Conditions
- Pathological Gambling
- Keywords
- Gambling, Gambler, Gamble, Pathological
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Sep 2006 (actual)
- First posted
- 9 Jan 2006 (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.
After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine 600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day at visit 6 unless clinical improvement has been attained at a lower dose (clinical improvement will be assessed by the investigator with respect to gambling thoughts, urges and behavior). If it is clinically necessary to modify this schedule (e.g., because of side effects or an adequate response to a lower dose), the dose will be raised more slowly or the target dose will not be reached.
Subjects will start no other psychotropic medications during the study but may continue on previously prescribed psychotropic medications if on a stable dose for 3 months prior to study entry. Psychotherapy of any form (including cognitive-behavioral therapy) will not be initiated during the study but subjects may continue with current psychotherapy if they have been undergoing therapy for at least three months prior to study entry.
Subjects will be evaluated with the PG-YBOCS, G-SAS, CGI, HAM-D, HAM-A and the Sheehan Disability Inventory at screening and at each visit for the remainder of the study. Medication side effects will be evaluated at each study visit. A tablet count will be kept for each dose of medication taken.
Detailed description
Before beginning N-Acetyl Cysteine, all subjects will receive a psychiatric, medical, and family history evaluation as well as the Structured Clinical Interview for DSM-IV (SCID-P) for Axis I disorders. At the screening visit, patients will also receive standard laboratory tests (including ß-HCG), and a physical examination.
The following instruments will be completed at the screening visit and periodically throughout the study: 1) Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling (PG-YBOCS), a reliable and valid semi-structured clinician-administered scale that assesses current severity of PG; 2) Gambling Symptom Assessment Scale (G-SAS), a reliable and valid self-report measure of gambling symptoms; 3) the 17-item Hamilton Rating Scale for Depression (HAM-D); 4) the 17-item Hamilton Rating Scale for Anxiety (HAM-A); 5) Clinical Global Impression scale; 6) the Sheehan Disability Inventory; and 7) the Quality of Life Inventory. Safety evaluations, including pulse and blood pressure, and assessment of side effects will be done at each visit.
After completing all screening evaluations, subjects will receive unblinded N-Acetyl Cysteine 600 mg/day for 2 weeks. The dose will be raised to 1200 mg/day at visit 4 and to 1800 mg/day at visit 6 unless clinical improvement has been attained at a lower dose (clinical improvement will be assessed by the investigator with respect to gambling thoughts, urges and behavior). If it is clinically necessary to modify this schedule (e.g., because of side effects or an adequate response to a lower dose), the dose will be raised more slowly or the target dose will not be reached.
Subjects will start no other psychotropic medications during the study but may continue on previously prescribed psychotropic medications if on a stable dose for 3 months prior to study entry. Psychotherapy of any form (including cognitive-behavioral therapy) will not be initiated during the study but subjects may continue with current psychotherapy if they have been undergoing therapy for at least three months prior to study entry.
Subjects will be evaluated with the PG-YBOCS, G-SAS, CGI, HAM-D, HAM-A and the Sheehan Disability Inventory at screening and at each visit for the remainder of the study. Medication side effects will be evaluated at each study visit. A tablet count will be kept for each dose of medication taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women age 18-65
- Current DSM-IV PG
Key exclusion criteria (10 listed)
- Unstable medical illness on physical examination
- History of seizures
- Myocardial infarction within 6 months
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Clinically significant suicidality
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-Acetyl Cysteine | Drug | – |
Primary outcome
PG-YBOCS
1 secondary outcome
G-SAS
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 30 Apr 2007.
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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.
Jon E Grant, MD, JD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing N-Acetyl Cysteine in people with Pathological Gambling, run by University of Minnesota 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 2 inclusion and 10 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 30 Apr 2007. 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 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.
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?
PG-YBOCS. 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 30 Apr 2007.