Bipolar DisorderPhase 1/2NCT00240110
Valproate Efficacy in Cocaine-Bipolar Comorbidity
A Phase 1/2 study testing Valproate and Lithium Carbonate in people with Bipolar Disorder and Cocaine Dependence, run by University of Miami at 2 sites in United States.
Trial summary
This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Cocaine Dependence
- What is being tested?
- Valproate and Lithium Carbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Mar 2014
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorder
Who cannot join
- Schizophrenia, schizoaffective, and any non-bipolar psychotic disorder, unipolar major depression, primary anxiety disorder, mental retardation, and signs of impaired cognitive functioning.
- Current DSM-IV criteria for dependence on substances other than cocaine, alcohol, cannabis, nicotine, or caffeine
- Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or documented focally abnormal EEG
- Medical conditions including severe cardiac, liver, kidney, or liver disease.
- Pregnancy
- Inability or unwillingness to use contraceptive methods
- Any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami Miller School of Medicine, Department of Psychiatry
Miami, Florida, 33136
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.
Read the detailed description
Bipolar disorder has the highest rate of association with cocaine and other substance use disorders than any other major severe psychiatric syndrome. This comorbidity represents a major treatment challenge and is associated with severe disability, morbidity, and heightened risk for suicide.
The aims of this study are:
- Examine the efficacy of valproate plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use in patients with cocaine dependence and comorbid bipolar disorder.
- Determine whether primary vs. secondary cocaine dependence, bipolar subtype (depressed vs. manic/mixed) and the presence of additional substance use disorders moderate the association between treatment and cocaine use outcome.
- Assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.
- Conditions
- Bipolar Disorder, Cocaine Dependence
- Being tested
- Valproate, Placebo, Lithium Carbonate
- Keywords
- Bipolar, Cocaine, Comorbidity
- Medical subject headings
- Bipolar Disorder, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValproateDrug
Also called Divalproex sodium
Valproate with dose titration to achieve blood levels within the therapeutic range
PlaceboDrug
Also called Placebo control
Control arm
Lithium CarbonateDrug
Also called Standard treatment
All participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder
| Study group | Role | What they receive |
|---|---|---|
| Lithium carbonate add on Placebo | Placebo comparator | Lithium carbonate started and stabilized then participants randomized to placebo Receives: Drug: Placebo; Drug: Lithium Carbonate |
| Lithium carbonate add on Valproate | Experimental | Lithium carbonate started and stabilized then participants randomized to Valproate Receives: Drug: Valproate; Drug: Lithium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Percentage of Cocaine-abstinent Days
Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)
Measured: Week 12
Secondary outcomes (1)
Change From Baseline in Percentage of Money Spent on Cocaine
Change from baseline in percentage of the amount of money spent on cocaine
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startMar 2006
- Primary completionMar 2014
- Study completionMar 2014
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 (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Ihsan Salloum, University of Miami
- Investigators
- Ihsan M Salloum, MD, MPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240110
- Sponsor's protocol ID
- 20070289
- Other IDs
- R01DA019992, 05080018, DPMCDA
- Status last verified
- Aug 2016
- First submitted
- 13 Oct 2005
- Last updated
- 17 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Salloum IM, Douaihy A, Cornelius JR, Kirisci L, Kelly TM, Hayes J. Divalproex utility in bipolar disorder with co-occurring cocaine dependence: a pilot study. Addict Behav. 2007 Feb;32(2):410-5. doi: 10.1016/j.addbeh.2006.05.007. Epub 2006 Jun 30.
PubMed 16814474
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valproate Efficacy in Cocaine-Bipolar Comorbidity
- ClinicalTrials.gov ID
- NCT00240110
- Acronym / sponsor ID
- 20070289
- Conditions
- Bipolar Disorder, Cocaine Dependence
- Keywords
- Bipolar, Cocaine, Comorbidity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2006
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Oct 2005 (estimated)
- Results
- Posted 17 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.
Detailed description
Bipolar disorder has the highest rate of association with cocaine and other substance use disorders than any other major severe psychiatric syndrome. This comorbidity represents a major treatment challenge and is associated with severe disability, morbidity, and heightened risk for suicide.
The aims of this study are:
- Examine the efficacy of valproate plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use in patients with cocaine dependence and comorbid bipolar disorder.
- Determine whether primary vs. secondary cocaine dependence, bipolar subtype (depressed vs. manic/mixed) and the presence of additional substance use disorders moderate the association between treatment and cocaine use outcome.
- Assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.
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 |
|---|---|---|
| Lithium carbonate add on Placebo | Placebo comparator | Drug: Placebo, Drug: Lithium CarbonateLithium carbonate started and stabilized then participants randomized to placebo |
| Lithium carbonate add on Valproate | Experimental | Drug: Valproate, Drug: Lithium CarbonateLithium carbonate started and stabilized then participants randomized to Valproate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorder
Key exclusion criteria (7 listed)
- Schizophrenia, schizoaffective, and any non-bipolar psychotic disorder, unipolar major depression, primary anxiety disorder, mental retardation, and signs of impaired cognitive functioning.
- Current DSM-IV criteria for dependence on substances other than cocaine, alcohol, cannabis, nicotine, or caffeine
- Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or documented focally abnormal EEG
- Medical conditions including severe cardiac, liver, kidney, or liver disease.
- Pregnancy
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 |
|---|---|---|
| ValproateAlso: Divalproex sodiumValproate with dose titration to achieve blood levels within the therapeutic range | Drug | Lithium carbonate add on Valproate |
| PlaceboAlso: Placebo controlControl arm | Drug | Lithium carbonate add on Placebo |
| Lithium CarbonateAlso: Standard treatmentAll participants were started and stabilized on lithium carbonate as a standard treatment for bipolar disorder | Drug | Lithium carbonate add on Placebo, Lithium carbonate add on Valproate |
Primary outcome
Change From Baseline in Percentage of Cocaine-abstinent Days
Time frame: Week 12
Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)
1 secondary outcome
Change From Baseline in Percentage of Money Spent on Cocaine
Time frame: week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16814474Salloum IM, Douaihy A, Cornelius JR, Kirisci L, Kelly TM, Hayes J. Divalproex utility in bipolar disorder with co-occurring cocaine dependence: a pilot study. Addict Behav. 2007 Feb;32(2):410-5. doi: 10.1016/j.addbeh.2006.05.007. Epub 2006 Jun 30.
- Individual participant dataSharing planned: No
Related trials for Bipolar Disorder
RecruitingPhase 4
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Depression, Bipolar
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
Recruiting
HD-tDCS for Adolescent Bipolar Depression Targeting S1
Adolescent, Bipolar Depression
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.
Ihsan M Salloum, MD, MPH principal investigator
University of Miami
2 sites 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 Valproate and Lithium Carbonate in people with Bipolar Disorder and Cocaine Dependence, run by University of Miami 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 1 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 17 Oct 2016. 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 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 17 Oct 2016). 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?
Change From Baseline in Percentage of Cocaine-abstinent Days (time frame: Week 12). 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 NCT00240110, which also lists 1 linked publication.
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 17 Oct 2016; AzTrials last refreshed its copy on 1 Nov 2026.