Alcohol DependenceNCT00570388
Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence
A study testing Prometa Treatment Program in people with Alcohol Dependence, run by Institute of Addiction Medicine at 1 site in United States.
Trial summary
This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment and this in turn will lead to improved ability to resist alcohol related cues and enhance involvement in psychosocial treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Prometa Treatment Program
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Sep 2008
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must meet DSM-IV criteria for current diagnosis of alcohol dependence.
- In the past 30 days, patient had an average of >15 standard alcohol drinks/week with at least one day of five or more drinks.
- Patient must have successfully completed detoxification from alcohol (abstinent for three consecutive days). As evidenced by self-report or three negative breathalyzer reading and a CIWA-Ar score less than 6.
- Patient understands and signs the consent.
Who cannot join
- Patients with a current DSM-IV diagnosis of any substance dependence other than alcohol, nicotine, or cannabis.
- Patients with a current or past history of DSM-IV diagnosis of Panic Disorder
- Evidence of benzodiazepine use in the past 15 days, determined by self-report and/or by a urine drug screen
- Patients with a seizure disorder being managed with a benzodiazepine or for whom a benzodiazepine is being considered
- Patients who are currently being treated with psychotropic medications, including disulfiram, naltrexone, or acamprosate at the time of study entry.
- Patients with a history of unstable or serious medical illness, including need for benzodiazepines.
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- Known severe physical or medical illnesses such as AIDS, active hepatitis,
- Current severe psychiatric symptoms, e.g., psychosis, dementia, acute suicidal or homicidal ideation, mania or depression requiring newly initiated antidepressant or psychotropic therapy, or which would make it unsafe for the patient to participate in the opinion of the primary investigator.
- Patients who have used investigational medication in the past 30 days.
- Female patients who are pregnant, nursing, or not using a reliable method of contraception.
- Patients with a condition that would make intravenous administration of medications difficult (e.g. absence of suitable peripheral veins).
- Have a known or hypersensitivity to medication components of PROMETA®TM
- Have been treated with PROMETA® for any reason currently or in the past year
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Institute of Addiction Medicine
Philadelphia, Pennsylvania, 19118
Jenny J Starosta, PhD, 215-248-6025, 2evolve@gmail.com
Joseph Volpicelli, MD, PhD, 215-248-6025, volpj@aol.com
About this study
This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment and this in turn will lead to improved ability to resist alcohol related cues and enhance involvement in psychosocial treatment.
Read the detailed description
The principal aim of this study is to extend our evaluation of the PROMETA® Treatment Protocol as a means to improve neurocognitive functioning in recently detoxified alcohol dependent subjects. For many alcohol dependent patients entering treatment, a range of neurocognitive deficits are present that not only had adverse effects on the patient's ability to function and think clearly but these deficits also impair the process of addiction treatment. For example, alcohol dependent subjects typically experience high levels of alcohol craving in the early stages of treatment. The patient is left with the choice of relieving craving by drinking alcohol to provide immediate relief of craving symptoms or abstaining from alcohol to obtain long-term benefits from recovery of the complications from excessive drinking. We have previously shown in open label trials that the PROMETA® Treatment Protocol helps stimulant abusers in the early stages of recovery, have relatively low rates of relapse to stimulant use. It is not clear if the Protocol is effective because of less urges to use stimulants or the ability to resist these urges is improved from a recovery of Neurocognitive functioning. The present proposal extends our previous research by comparing the efficacy of the PROMETA® Treatment Protocol in a double blind placebo controlled trial using a new population of substance abusers (alcohol dependent subjects) and assessing the effects of the PROMETA® Treatment Protocol on neurocognitive functioning, particularly those aspects of functioning that affect the ability to make decisions that have important long-term benefits.
- Conditions
- Alcohol Dependence
- Being tested
- Prometa Treatment Program
- Keywords
- Neurocognitive, Alcohol Dependence, Prometa, Prometa Protocol, Starosta
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prometa Treatment ProgramDrug
Day 1-3•Hydroxyzine HCL 50 mg and multivitamins with minerals po one hour before flumazenil infusion. Flumazenil infusion.
Day 1•Gabapentin 300 mg po 9PM w/ hydroxyzine HCL 50 mg PRN for sleep.
Day 2•Gabapentin 600 mg po 9PM w/ hydroxyzine HCL 50 mg PRN
Day 3•Gabapentin 900 mg po 9PM w/ hydroxyzine HCL 50 mg PRN
Days 4 through 28•Gabapentin 1200 mg po 9 PM
Days 29 through 31•Gabapentin 900 mg po 9 PM
Days 32 through 34•Gabapentin 600 mg po 9 PM
Days 35 through 38•Gabapentin 300 mg po 9 PM
Flumazenil Dosing Schedule
2 mg flumazenil is given as a slow IV push. Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine; subjects in the active group will receive flumazenil, gabapentin, and hydroxyzine per protocol.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Subjects in the active Prometa group will receive flumazenil, gabapentin, and hydroxyzine per the Prometa Protocol. Receives: Drug: Prometa Treatment Program |
| 1 | Placebo comparator | Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine Receives: Drug: Prometa Treatment Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is neurocognitive functioning as assessed by a battery of standardized neurocognitive tests that assess, executive functioning, verbal memory, general intelligence, and attention.
Measured: Time Frame: Eight Weeks
Secondary outcomes (1)
Secondary outcome measures include, alcohol craving, subject retention, percent of abstinent days, percent of heavy drinking days, time to first heavy drinking day, and blood chemistries including liver enzymes, reports of side effects.
Measured: Eight Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2007 (estimated)
- Study startMar 2007
- Study completionSep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Addiction Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Jenny J Starosta, PhD, Principal investigator, Institute of Addiction MedicineJoseph Volpicelli, MD, PhD, Principal investigator, Institute of Addiction Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570388
- Sponsor's protocol ID
- 20062166
- Other IDs
- WIRB Protocol Number: 20062166, WIRB Study Number: 1085483, WIRB Invest. Number: 128549
- Status last verified
- Jan 2008
- First submitted
- 6 Dec 2007
- Last updated
- 16 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Matching alcoholism treatments to client heterogeneity: treatment main effects and matching effects on drinking during treatment. Project MATCH Research Group. J Stud Alcohol. 1998 Nov;59(6):631-9. doi: 10.15288/jsa.1998.59.631.
PubMed 9811084Barker MJ, Greenwood KM, Jackson M, Crowe SF. Cognitive effects of long-term benzodiazepine use: a meta-analysis. CNS Drugs. 2004;18(1):37-48. doi: 10.2165/00023210-200418010-00004.
PubMed 14731058Bates ME, Pawlak AP, Tonigan JS, Buckman JF. Cognitive impairment influences drinking outcome by altering therapeutic mechanisms of change. Psychol Addict Behav. 2006 Sep;20(3):241-53. doi: 10.1037/0893-164X.20.3.241.
PubMed 16938062Girdler NM, Lyne JP, Wallace R, Neave N, Scholey A, Wesnes KA, Herman C. A randomised, controlled trial of cognitive and psychomotor recovery from midazolam sedation following reversal with oral flumazenil. Anaesthesia. 2002 Sep;57(9):868-76. doi: 10.1046/j.1365-2044.2002.02785.x.
PubMed 12190751Mason BJ. Treatment of alcohol-dependent outpatients with acamprosate: a clinical review. J Clin Psychiatry. 2001;62 Suppl 20:42-8.
PubMed 11584875Mason BJ, Goodman AM, Chabac S, Lehert P. Effect of oral acamprosate on abstinence in patients with alcohol dependence in a double-blind, placebo-controlled trial: the role of patient motivation. J Psychiatr Res. 2006 Aug;40(5):383-93. doi: 10.1016/j.jpsychires.2006.02.002. Epub 2006 Mar 20.
PubMed 16546214Rupp CI, Fleischhacker WW, Drexler A, Hausmann A, Hinterhuber H, Kurz M. Executive function and memory in relation to olfactory deficits in alcohol-dependent patients. Alcohol Clin Exp Res. 2006 Aug;30(8):1355-62. doi: 10.1111/j.1530-0277.2006.00162.x.
PubMed 16899038Singh N, Sharma A, Singh M. Possible mechanism of alprazolam-induced amnesia in mice. Pharmacology. 1998 Jan;56(1):46-50. doi: 10.1159/000028181.
PubMed 9467187Srisurapanont M, Jarusuraisin N. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001867. doi: 10.1002/14651858.CD001867.pub2.
PubMed 15674887Stewart SA. The effects of benzodiazepines on cognition. J Clin Psychiatry. 2005;66 Suppl 2:9-13.
PubMed 15762814Tapert SF, Ozyurt SS, Myers MG, Brown SA. Neurocognitive ability in adults coping with alcohol and drug relapse temptations. Am J Drug Alcohol Abuse. 2004 May;30(2):445-60. doi: 10.1081/ada-120037387.
PubMed 15230085Uekermann J, Daum I, Schlebusch P, Wiebel B, Trenckmann U. Depression and cognitive functioning in alcoholism. Addiction. 2003 Nov;98(11):1521-9. doi: 10.1046/j.1360-0443.2003.00526.x.
PubMed 14616178Zinn S, Stein R, Swartzwelder HS. Executive functioning early in abstinence from alcohol. Alcohol Clin Exp Res. 2004 Sep;28(9):1338-46. doi: 10.1097/01.alc.0000139814.81811.62.
PubMed 15365304
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Functioning Following The PROMETA® Treatment Protocol In Subjects With Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00570388
- Acronym / sponsor ID
- 20062166
- Conditions
- Alcohol Dependence
- Keywords
- Neurocognitive, Alcohol Dependence, Prometa, Prometa Protocol, Starosta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institute of Addiction MedicineUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Sep 2008 (estimated)
- First posted
- 10 Dec 2007 (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.
This study will test the safety and efficacy of the PROMETA® Treatment Protocol (which includes the benzodiazepine antagonist flumazenil) in reversing the neurocognitive impairment and this in turn will lead to improved ability to resist alcohol related cues and enhance involvement in psychosocial treatment.
Detailed description
The principal aim of this study is to extend our evaluation of the PROMETA® Treatment Protocol as a means to improve neurocognitive functioning in recently detoxified alcohol dependent subjects. For many alcohol dependent patients entering treatment, a range of neurocognitive deficits are present that not only had adverse effects on the patient's ability to function and think clearly but these deficits also impair the process of addiction treatment. For example, alcohol dependent subjects typically experience high levels of alcohol craving in the early stages of treatment. The patient is left with the choice of relieving craving by drinking alcohol to provide immediate relief of craving symptoms or abstaining from alcohol to obtain long-term benefits from recovery of the complications from excessive drinking. We have previously shown in open label trials that the PROMETA® Treatment Protocol helps stimulant abusers in the early stages of recovery, have relatively low rates of relapse to stimulant use. It is not clear if the Protocol is effective because of less urges to use stimulants or the ability to resist these urges is improved from a recovery of Neurocognitive functioning. The present proposal extends our previous research by comparing the efficacy of the PROMETA® Treatment Protocol in a double blind placebo controlled trial using a new population of substance abusers (alcohol dependent subjects) and assessing the effects of the PROMETA® Treatment Protocol on neurocognitive functioning, particularly those aspects of functioning that affect the ability to make decisions that have important long-term benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: Prometa Treatment ProgramSubjects in the active Prometa group will receive flumazenil, gabapentin, and hydroxyzine per the Prometa Protocol. |
| 1 | Placebo comparator | Drug: Prometa Treatment ProgramSubjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must meet DSM-IV criteria for current diagnosis of alcohol dependence.
- In the past 30 days, patient had an average of >15 standard alcohol drinks/week with at least one day of five or more drinks.
- Patient must have successfully completed detoxification from alcohol (abstinent for three consecutive days). As evidenced by self-report or three negative breathalyzer reading and a CIWA-Ar score less than 6.
- Patient understands and signs the consent.
Key exclusion criteria (13 listed)
- Patients with a current DSM-IV diagnosis of any substance dependence other than alcohol, nicotine, or cannabis.
- Patients with a current or past history of DSM-IV diagnosis of Panic Disorder
- Evidence of benzodiazepine use in the past 15 days, determined by self-report and/or by a urine drug screen
- Patients with a seizure disorder being managed with a benzodiazepine or for whom a benzodiazepine is being considered
- Patients who are currently being treated with psychotropic medications, including disulfiram, naltrexone, or acamprosate at the time of study entry.
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 |
|---|---|---|
| Prometa Treatment ProgramDay 1-3•Hydroxyzine HCL 50 mg and multivitamins with minerals po one hour before flumazenil infusion. Flumazenil infusion. Day 1•Gabapentin 300 mg po 9PM w/ hydroxyzine HCL 50 mg PRN for sleep. Day 2•Gabapentin 600 mg po 9PM w/ hydroxyzine HCL 50 mg PRN Day 3•Gabapentin 900 mg po 9PM w/ hydroxyzine HCL 50 mg PRN Days 4 through 28•Gabapentin 1200 mg po 9 PM Days 29 through 31•Gabapentin 900 mg po 9 PM Days 32 through 34•Gabapentin 600 mg po 9 PM Days 35 through 38•Gabapentin 300 mg po 9 PM Flumazenil Dosing Schedule 2 mg flumazenil is given as a slow IV push. Subjects in the "placebo group" will receive placebo flumazenil, gabapentin, and hydroxyzine; subjects in the active group will receive flumazenil, gabapentin, and hydroxyzine per protocol. | Drug | 1, 2 |
Primary outcome
The primary outcome measure is neurocognitive functioning as assessed by a battery of standardized neurocognitive tests that assess, executive functioning, verbal memory, general intelligence, and attention.
Time frame: Time Frame: Eight Weeks
1 secondary outcome
Secondary outcome measures include, alcohol craving, subject retention, percent of abstinent days, percent of heavy drinking days, time to first heavy drinking day, and blood chemistries including liver enzymes, reports of side effects.
Time frame: Eight Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2008.
- Background: PubMed 9811084Matching alcoholism treatments to client heterogeneity: treatment main effects and matching effects on drinking during treatment. Project MATCH Research Group. J Stud Alcohol. 1998 Nov;59(6):631-9. doi: 10.15288/jsa.1998.59.631.
- Background: PubMed 14731058Barker MJ, Greenwood KM, Jackson M, Crowe SF. Cognitive effects of long-term benzodiazepine use: a meta-analysis. CNS Drugs. 2004;18(1):37-48. doi: 10.2165/00023210-200418010-00004.
- Background: PubMed 16938062Bates ME, Pawlak AP, Tonigan JS, Buckman JF. Cognitive impairment influences drinking outcome by altering therapeutic mechanisms of change. Psychol Addict Behav. 2006 Sep;20(3):241-53. doi: 10.1037/0893-164X.20.3.241.
- Background: PubMed 12190751Girdler NM, Lyne JP, Wallace R, Neave N, Scholey A, Wesnes KA, Herman C. A randomised, controlled trial of cognitive and psychomotor recovery from midazolam sedation following reversal with oral flumazenil. Anaesthesia. 2002 Sep;57(9):868-76. doi: 10.1046/j.1365-2044.2002.02785.x.
- Background: PubMed 11584875Mason BJ. Treatment of alcohol-dependent outpatients with acamprosate: a clinical review. J Clin Psychiatry. 2001;62 Suppl 20:42-8.
- Background: PubMed 16546214Mason BJ, Goodman AM, Chabac S, Lehert P. Effect of oral acamprosate on abstinence in patients with alcohol dependence in a double-blind, placebo-controlled trial: the role of patient motivation. J Psychiatr Res. 2006 Aug;40(5):383-93. doi: 10.1016/j.jpsychires.2006.02.002. Epub 2006 Mar 20.
- Background: PubMed 16899038Rupp CI, Fleischhacker WW, Drexler A, Hausmann A, Hinterhuber H, Kurz M. Executive function and memory in relation to olfactory deficits in alcohol-dependent patients. Alcohol Clin Exp Res. 2006 Aug;30(8):1355-62. doi: 10.1111/j.1530-0277.2006.00162.x.
- Background: PubMed 9467187Singh N, Sharma A, Singh M. Possible mechanism of alprazolam-induced amnesia in mice. Pharmacology. 1998 Jan;56(1):46-50. doi: 10.1159/000028181.
- Background: PubMed 15674887Srisurapanont M, Jarusuraisin N. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001867. doi: 10.1002/14651858.CD001867.pub2.
- Background: PubMed 15762814Stewart SA. The effects of benzodiazepines on cognition. J Clin Psychiatry. 2005;66 Suppl 2:9-13.
- Background: PubMed 15230085Tapert SF, Ozyurt SS, Myers MG, Brown SA. Neurocognitive ability in adults coping with alcohol and drug relapse temptations. Am J Drug Alcohol Abuse. 2004 May;30(2):445-60. doi: 10.1081/ada-120037387.
- Background: PubMed 14616178Uekermann J, Daum I, Schlebusch P, Wiebel B, Trenckmann U. Depression and cognitive functioning in alcoholism. Addiction. 2003 Nov;98(11):1521-9. doi: 10.1046/j.1360-0443.2003.00526.x.
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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.
Jenny J Starosta, PhD principal investigator
Institute of Addiction Medicine
Joseph Volpicelli, MD, PhD principal investigator
Institute of Addiction Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prometa Treatment Program in people with Alcohol Dependence, run by Institute of Addiction Medicine 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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 16 Jan 2008. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenny J Starosta, PhD (215-248-6025, 2evolve@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is neurocognitive functioning as assessed by a battery of standardized neurocognitive tests that assess, executive functioning, verbal memory, general intelligence, and attention. (time frame: Time Frame: Eight 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 NCT00570388, which also lists 13 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 16 Jan 2008.