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Trial record 2 of 4 for:    salloum | Miami, Florida, U.S.

Valproate Efficacy in Cocaine-Bipolar Comorbidity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00240110
Recruitment Status : Completed
First Posted : October 17, 2005
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Ihsan Salloum, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Cocaine Dependence
Interventions Drug: Valproate
Drug: Placebo
Drug: Lithium Carbonate
Enrollment 152
Recruitment Details  
Pre-assignment Details High screen failure for not meeting inclusion/exclusion criteria and for lost to follow-up during screening
Arm/Group Title Lithium Carbonate Add on Placebo Lithium Carbonate Add on Valproate
Hide Arm/Group Description Lithium started and then participants randomized to placebo Lithium carbonate started and participants randomized to valproate
Period Title: Overall Study
Started 13 13
Completed 7 6
Not Completed 6 7
Reason Not Completed
Lost to Follow-up             6             7
Arm/Group Title Lithium Carbonate Add on Placebo Lithium Carbonate Add on Valproate Total
Hide Arm/Group Description Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
 100.0%
13
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
46.7  (7.4) 44  (7.7) 45.4  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
5
  38.5%
5
  38.5%
10
  38.5%
Male
8
  61.5%
8
  61.5%
16
  61.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Hispanic or Latino
2
  15.4%
4
  30.8%
6
  23.1%
Not Hispanic or Latino
11
  84.6%
9
  69.2%
20
  76.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  53.8%
7
  53.8%
14
  53.8%
White
6
  46.2%
6
  46.2%
12
  46.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Percentage of Cocaine-abstinent Days
Hide Description Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data after assignment to study medications
Arm/Group Title Lithium Carbonate Add on Placebo Lithium Carbonate Add on Valproate
Hide Arm/Group Description:
Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: percentage of days cocaine abstinent
16.4  (29.7) 14.5  (20.3)
2.Secondary Outcome
Title Change From Baseline in Percentage of Money Spent on Cocaine
Hide Description Change from baseline in percentage of the amount of money spent on cocaine
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects with available data after assignment to study medications
Arm/Group Title Lithium Carbonate Add on Placebo Lithium Carbonate Add on Valproate
Hide Arm/Group Description:
Open label lithium carbonate as standard treatment and double blinded placebo
Open label lithium carbonate as standard treatment and double blinded valproate
Overall Number of Participants Analyzed 11 12
Mean (Standard Deviation)
Unit of Measure: Percentage of Money Spent on Cocaine
-43.6  (58.4) -34.9  (56.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lithium Carbonate Add on Placebo Lithium Carbonate Add on Valproate
Hide Arm/Group Description Lithium carbonate as standard treatment add on double blind placebo Lithium carbonate as standard treatment add on double blind valproate
All-Cause Mortality
Lithium Carbonate Add on Placebo Lithium Carbonate Add on Valproate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Lithium Carbonate Add on Placebo Lithium Carbonate Add on Valproate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      1/13 (7.69%)    
Psychiatric disorders     
Hospitalization * 1 [1]  0/13 (0.00%)  0 1/13 (7.69%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Standard terminology
[1]
worsening related to substance abuse (benzodiazepines and opioids) led to excessive sedation and admission
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lithium Carbonate Add on Placebo Lithium Carbonate Add on Valproate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/13 (76.92%)      10/13 (76.92%)    
Cardiac disorders     
Heart palpatation  1  1/13 (7.69%)  1/13 (7.69%) 
Gastrointestinal disorders     
Nausea, diarrhea  1  6/13 (46.15%)  6/13 (46.15%) 
General disorders     
Headache  1  4/13 (30.77%)  3/13 (23.08%) 
Fall  1  0/13 (0.00%)  2/13 (15.38%) 
Musculoskeletal and connective tissue disorders     
Back wrist pain  1  3/13 (23.08%)  5/13 (38.46%) 
Psychiatric disorders     
Restless, sleepless  1  4/13 (30.77%)  5/13 (38.46%) 
Renal and urinary disorders     
Increased urination  1  3/13 (23.08%)  3/13 (23.08%) 
Reproductive system and breast disorders     
sexual dysfunction  1  1/13 (7.69%)  1/13 (7.69%) 
increased menses  1  1/13 (7.69%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ihsan Salloum
Organization: Univeristy of Miami
Phone: 305-243-7931
EMail: isalloum@med.miami.edu
Layout table for additonal information
Responsible Party: Ihsan Salloum, University of Miami
ClinicalTrials.gov Identifier: NCT00240110    
Other Study ID Numbers: 20070289
R01DA019992 ( U.S. NIH Grant/Contract )
05080018 ( Other Identifier: NIDA )
DPMCDA ( Other Identifier: NIDA )
First Submitted: October 13, 2005
First Posted: October 17, 2005
Results First Submitted: June 30, 2015
Results First Posted: October 17, 2016
Last Update Posted: October 17, 2016