Alcohol DependencePhase 3NCT00448825
Novel Pharmacotherapy for Dual Dependence
A Phase 3 study testing Topiramate + Cognitive Behavioral Therapy in people with Alcohol Dependence and Cocaine Dependence, run by Bankole Johnson at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Dependence, Cocaine Dependence
- What is being tested?
- Topiramate + Cognitive Behavioral Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Jun 2013
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be men and women between the ages of 18 years and older.
- Must meet at least three of the seven DSM IV diagnostic criteria for alcohol and cocaine dependence.
- Express a desire for treatment.
- Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments are required.
- Prospective subjects must report cocaine use of at least once per month and alcohol consumption of ≥21 drinks/week and ≥14 drinks/week for men and women respectively, during the past 30 days
- At least one positive urine drug screen for cocaine at screen or baseline prior to randomization.
Who cannot join
- Please contact site for additional information
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Virginia Center for Addiction Research and Education
Charlottesville, Virginia, 22911
Mindy Borszich, 888-882-2345, mcb3x@virginia.edu
Eva Jenkins-Mendoza, (434)243-0562, emj9c@virginia.edu
- Recruiting
University of Virginia Center for Addiction Research and Education
Richmond, Virginia, 23294
Mindy Borszich, 888-882-2345, mcb3x@virginia.edu
Eva Jenkins-Mendoza, (434)243-0562, emj9c@virginia.edu
About this study
The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.
Read the detailed description
Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence.
Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of treatment.
- Conditions
- Alcohol Dependence, Cocaine Dependence
- Being tested
- Topiramate + Cognitive Behavioral Therapy, Placebo + Cognitive Behavioral Therapy
- Keywords
- alcohol dependence, alcoholism, cocaine addiction, cocaine dependence
- Medical subject headings
- Alcoholism, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topiramate + Cognitive Behavioral TherapyDrug
Also called Topamax
Topiramate up to 300 mg per day
Placebo + Cognitive Behavioral TherapyDrug
Also called Sugar Pill
Placebo twice a day
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Experimental | Topiramate + Cognitive Behavioral Therapy Receives: Drug: Topiramate + Cognitive Behavioral Therapy |
| Placebo | Placebo comparator | Placebo + Cognitive Behavioral Therapy Receives: Drug: Placebo + Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol.
Alcohol - assessed by self-report of use (TLFB,DD,DDD,PDA, PHDD), biochemical markers (GGT, CDT), OCDS
Cocaine - assessed by self-report of use (CTFB, substance use inventory, QFI),urine assay for benzoylecgonine, and CCQ-NOW
Measured: According to Preston Rules from weeks 6 to 12.
Secondary outcomes (1)
a. Cocaine free weeks; b. Topiramate, compared with placebo, will be associated with an improvement in psychosocial functioning as exemplified by improved general well-being, social functioning, and quality of life.
- Cocaine free weeks is assessed by a combination of self-report of use and urine assays;
- Assessed by increased scores in the following assessments: CGI, BSI, Q-LES-Q, DrInC, SFQ, medication compliance, CIWA-Ar, POMS, BIS
Measured: According to Preston Rules from weeks 1 to 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionJun 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bankole Johnson
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Bankole Johnson, University of Virginia
- Investigators
- Bankole Johnson, DSc, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448825
- Sponsor's protocol ID
- 11620
- Other IDs
- R01DA019804, DPMCDA
- Status last verified
- Mar 2013
- First submitted
- 15 Mar 2007
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Pharmacotherapy for Dual Dependence
- ClinicalTrials.gov ID
- NCT00448825
- Acronym / sponsor ID
- 11620
- Conditions
- Alcohol Dependence, Cocaine Dependence
- Keywords
- alcohol dependence, alcoholism, cocaine addiction, cocaine dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Bankole JohnsonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2007
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 19 Mar 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.
The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.
Detailed description
Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence.
Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Experimental | Drug: Topiramate + Cognitive Behavioral TherapyTopiramate + Cognitive Behavioral Therapy |
| Placebo | Placebo comparator | Drug: Placebo + Cognitive Behavioral TherapyPlacebo + Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects will be men and women between the ages of 18 years and older.
- Must meet at least three of the seven DSM IV diagnostic criteria for alcohol and cocaine dependence.
- Express a desire for treatment.
- Literacy in English and ability to read, understand, and complete the ratings scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments are required.
- Prospective subjects must report cocaine use of at least once per month and alcohol consumption of ≥21 drinks/week and ≥14 drinks/week for men and women respectively, during the past 30 days
Key exclusion criteria (1 listed)
- Please contact site for additional information
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 |
|---|---|---|
| Topiramate + Cognitive Behavioral TherapyAlso: TopamaxTopiramate up to 300 mg per day | Drug | Topiramate |
| Placebo + Cognitive Behavioral TherapyAlso: Sugar PillPlacebo twice a day | Drug | Placebo |
Primary outcome
The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol.
Time frame: According to Preston Rules from weeks 6 to 12.
Alcohol - assessed by self-report of use (TLFB,DD,DDD,PDA, PHDD), biochemical markers (GGT, CDT), OCDS Cocaine - assessed by self-report of use (CTFB, substance use inventory, QFI),urine assay for benzoylecgonine, and CCQ-NOW
1 secondary outcome
a. Cocaine free weeks; b. Topiramate, compared with placebo, will be associated with an improvement in psychosocial functioning as exemplified by improved general well-being, social functioning, and quality of life.
Time frame: According to Preston Rules from weeks 1 to 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
Related trials for Alcohol Dependence
Active, not recruitingPhase 2
Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder
Alcohol Use Disorder
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
Not yet recruiting
Connecting Online Military Personnel to Alcohol Harm-reducing Smartphone Support Study
Alcohol Use Disorder (AUD)
RecruitingPhase 4
Temporally-Resolved Electrophysiology of Acamprosate Treatment of Alcohol Use Disorder
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
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.
Bankole Johnson, DSc, MD, PhD principal investigator
University of Virginia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topiramate + Cognitive Behavioral Therapy in people with Alcohol Dependence and Cocaine Dependence, run by Bankole Johnson at 2 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 6 inclusion and 1 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 15 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mindy Borszich (1-888-882-2345, mcb3x@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The topiramate group will be superior to the placebo group on the following outcome measures:increasing the weekly mean proportion of cocaine-free days, decreasing self-reported drinking, and decreasing craving for cocaine and alcohol. (time frame: According to Preston Rules from weeks 6 to 12.). 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 15 Mar 2013.