Stimulant DependenceNCT00628927
An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.
An observational study of Stimulant Dependence, run by University of Cincinnati at 6 sites in United States.
Trial summary
The purpose of this study is to determine whether performance on neurocognitive measures predicts treatment outcomes in individuals with substance abuse disorders. A second purpose is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in people with substance abuse disorders to that… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stimulant Dependence
- How many people
- 217 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2008to Mar 2010
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Persons randomized into the National Drug Abuse Treatment Clinical Trials Network STAGE-12 Study (CTN-0031- NCT00573183)
Who may be able to join
- be randomized into the CTN-0031 (STAGE-12) trial
- current abuse or dependence for METH and/or cocaine
- endorse METH and/or cocaine as the primary drug of choice
- able to correctly distinguish the colored stimuli on the Stoop task.
Who cannot join
- history of stroke
- history of a seizure disorder
- Inclusion Criteria (Non-METH and/or Cocaine Dependent Group):
- be 18 years of age or older
- be able to understand the study and provide written informed consent in English
- Exclusion Criteria (Non-METH and/or Cocaine Dependent Group):
Show all 14Show fewer
- history of stroke
- history of a seizure disorder
- positive urine toxicology screen
- screen positive for Major Depressive Syndrome, other Depressive Syndrome, Panic Syndrome, or other Anxiety Syndrome
- meet criteria for ADHD
- have HIV/AIDS
- history of an injury in which consciousness was lost for more than 30 minutes
- meet DSM-IV criteria for dependence (either current or lifetime) for any psychoactive substance other than nicotine or for abuse (both current and lifetime) for any psychoactive substance other than nicotine or for alcohol for which a life-time history of abuse is allowed
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Maryhaven
Columbus, Ohio, 43207
Nexus Recovery Center
Dallas, Texas, 75228
Willamette Family Treatment Services
Eugene, Oregon, 97402
Gateway Community Services
Jacksonville, Florida, 32211
ChangePoint, Inc.
Portland, Oregon, 97292
Recovery Centers of King County
Seattle, Washington, 98122
About this study
Official title: An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers
The purpose of this study is to determine whether performance on neurocognitive measures predicts treatment outcomes in individuals with substance abuse disorders. A second purpose is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in people with substance abuse disorders to that of people who do not have substance abuse disorders.
Read the detailed description
The primary objective of this study is to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with Methamphetamine use disorders. Secondary objectives include evaluating whether:
- performance on various neurocognitive measures, including the Stroop, Rey Auditory-Verbal Learning Test (RAVLT), Iowa Gambling Task (GT), Wisconsin Card Sorting Task (WCST), the Barratt Impulsiveness Scale version -11 (BIS-11), and the Frontal Systems Behavior Scale (FrSBe) is predictive of treatment attrition and stimulant use outcomes in METH/cocaine abusers;
- neurocognitive test performance is associated with oxidative damage, a severe consequence of oxidative stress, in METH/cocaine abusers;
- oxidative damage is predictive of treatment attrition and substance use outcomes in METH/cocaine abusers,
- oxidative damage in METH/cocaine abusers is significantly greater than that of a normal comparison group and
- exploratory analyses reveal a significant relationship among oxidative stress, neurocognitive function, and treatment outcomes in METH/cocaine abusers.
- Conditions
- Stimulant Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| METH and/or cocaine dependent group | The METH and/or cocaine dependent group were also enrolled in CTN0031 (NCT00573183) and seeking treatment. This group will be analyzed based on whether or not they completed treatment as defined by the study. | |
| Non METH and/or cocaine dependent group | The Non METH and/or cocaine dependent group participants are normal controls recruited from the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroop Color-word Task
The primary objective of this study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders (Streeter et al., 2007) and to extend this finding to participants with methamphetamine use disorders. In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ''red'' might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial.
Measured: Single study visit
Secondary outcomes (2)
Barrett Impulsiveness Scale Version 11 (BIS-11)
The BIS-11 consists of 30 self-report items, with responses in a four-point Likert-type scale (0 - 3)ranging from "Rarely/Never" to "Almost Always/Always" and comprises three domains: Attentional impulsiveness (AI), Motor impulsiveness (MI), and Non-planning impulsiveness (NP); these three domains are summed to yield a total score; higher scores reflect greater impulsivity. The total score was utilized as the BIS-11 predictor measure (possible score range 0 - 90).
Measured: Single study visit
Tail Length From the Comet Assay for Oxidative Damage
The test for oxidative damage was derived from a blood sample which was analyzed for tail length from the comet assay; higher scores reflect greater oxidative damage.
Measured: Single study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionOct 2009
- Study completionMar 2010
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stimulant DependenceStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Theresa Winhusen, University of Cincinnati
- Investigators
- Theresa Winhusen, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628927
- Sponsor's protocol ID
- NIDA-CTN-0031A
- Other IDs
- 5U10DA013732, U10DA013732
- Status last verified
- Dec 2015
- First submitted
- 3 Mar 2008
- Last updated
- 30 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Winhusen TM, Somoza EC, Lewis DF, Kropp FB, Horigian VE, Adinoff B. Frontal systems deficits in stimulant-dependent patients: evidence of pre-illness dysfunction and relationship to treatment response. Drug Alcohol Depend. 2013 Jan 1;127(1-3):94-100. doi: 10.1016/j.drugalcdep.2012.06.017. Epub 2012 Jul 6.
PubMed 22771145Winhusen T, Walker J, Brigham G, Lewis D, Somoza E, Theobald J, Somoza V. Preliminary evaluation of a model of stimulant use, oxidative damage and executive dysfunction. Am J Drug Alcohol Abuse. 2013 Jul;39(4):227-34. doi: 10.3109/00952990.2013.798663. Epub 2013 Jun 28.
PubMed 23808868
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Neurocognitive Function, Oxidative Damage, and Their Association With Treatment Outcomes in Methamphetamine and Cocaine Abusers
- ClinicalTrials.gov ID
- NCT00628927
- Acronym / sponsor ID
- NIDA-CTN-0031A
- Conditions
- Stimulant Dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Posted 30 Aug 2013
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 study is to determine whether performance on neurocognitive measures predicts treatment outcomes in individuals with substance abuse disorders. A second purpose is to compare the risk of damage, as well as actual damage, to DNA and other cell parts in people with substance abuse disorders to that of people who do not have substance abuse disorders.
Detailed description
The primary objective of this study is to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders and to extend this finding to participants with Methamphetamine use disorders. Secondary objectives include evaluating whether:
- performance on various neurocognitive measures, including the Stroop, Rey Auditory-Verbal Learning Test (RAVLT), Iowa Gambling Task (GT), Wisconsin Card Sorting Task (WCST), the Barratt Impulsiveness Scale version -11 (BIS-11), and the Frontal Systems Behavior Scale (FrSBe) is predictive of treatment attrition and stimulant use outcomes in METH/cocaine abusers;
- neurocognitive test performance is associated with oxidative damage, a severe consequence of oxidative stress, in METH/cocaine abusers;
- oxidative damage is predictive of treatment attrition and substance use outcomes in METH/cocaine abusers,
- oxidative damage in METH/cocaine abusers is significantly greater than that of a normal comparison group and
- exploratory analyses reveal a significant relationship among oxidative stress, neurocognitive function, and treatment outcomes in METH/cocaine abusers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| METH and/or cocaine dependent group | – | –The METH and/or cocaine dependent group were also enrolled in CTN0031 (NCT00573183) and seeking treatment. This group will be analyzed based on whether or not they completed treatment as defined by the study. |
| Non METH and/or cocaine dependent group | – | –The Non METH and/or cocaine dependent group participants are normal controls recruited from the community. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Persons randomized into the National Drug Abuse Treatment Clinical Trials Network STAGE-12 Study (CTN-0031- NCT00573183)
Key inclusion criteria (4 listed)
- be randomized into the CTN-0031 (STAGE-12) trial
- current abuse or dependence for METH and/or cocaine
- endorse METH and/or cocaine as the primary drug of choice
- able to correctly distinguish the colored stimuli on the Stoop task.
Key exclusion criteria (14 listed)
- history of stroke
- history of a seizure disorder
- be 18 years of age or older
- be able to understand the study and provide written informed consent in English
- history of stroke
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
Stroop Color-word Task
Time frame: Single study visit
The primary objective of this study was to replicate the finding that performance on the Stroop color-word interference task is predictive of treatment completion in participants with cocaine use disorders (Streeter et al., 2007) and to extend this finding to participants with methamphetamine use disorders. In the Stroop, the participant is required to name the color of the ink in which a word is printed while inhibiting the overlearned response of reading the word (e.g., the word ''red'' might be printed in blue ink). The number of errors were subtracted from the time required (RT; Reaction Time) for each of the 3 trials, yielding three summary scores. The derived interference score is obtained by subtracting the RT for the first trial from the RT for the third trial.
2 secondary outcomes
Barrett Impulsiveness Scale Version 11 (BIS-11)
Time frame: Single study visit
Tail Length From the Comet Assay for Oxidative Damage
Time frame: Single study visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22771145Winhusen TM, Somoza EC, Lewis DF, Kropp FB, Horigian VE, Adinoff B. Frontal systems deficits in stimulant-dependent patients: evidence of pre-illness dysfunction and relationship to treatment response. Drug Alcohol Depend. 2013 Jan 1;127(1-3):94-100. doi: 10.1016/j.drugalcdep.2012.06.017. Epub 2012 Jul 6.
- Derived from this study: PubMed 23808868Winhusen T, Walker J, Brigham G, Lewis D, Somoza E, Theobald J, Somoza V. Preliminary evaluation of a model of stimulant use, oxidative damage and executive dysfunction. Am J Drug Alcohol Abuse. 2013 Jul;39(4):227-34. doi: 10.3109/00952990.2013.798663. Epub 2013 Jun 28.
Related trials for Stimulant Dependence
Recruiting
rTMS for Craving in Methamphetamine Use Disorder
Methamphetamine Abuse, Substance Use Disorders
RecruitingPhase 2
Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
Methamphetamine Abuse, Methamphetamine-dependence
RecruitingPhase 2
Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users
Methamphetamine Abuse, Methamphetamine-dependence
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.
Theresa Winhusen, Ph.D. principal investigator
University of Cincinnati
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stimulant Dependence, run by University of Cincinnati at 6 sites 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 4 inclusion and 14 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 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Yes. Results are posted in the registry (first posted 30 Aug 2013). 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?
Stroop Color-word Task (time frame: Single study visit). 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 NCT00628927, which also lists 2 linked publications.
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 Dec 2015.