Trial Outcomes & Findings for Valproate Efficacy in Cocaine-Bipolar Comorbidity (NCT NCT00240110)

NCT ID: NCT00240110

Last Updated: 2016-10-17

Results Overview

Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 152 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2016-10-17

Participant Flow

High screen failure for not meeting inclusion/exclusion criteria and for lost to follow-up during screening

Participant milestones

Measure	Lithium Carbonate Add on Placebo Lithium started and then participants randomized to placebo	Lithium Carbonate Add on Valproate Lithium carbonate started and participants randomized to valproate
Overall Study STARTED	13	13
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	6	7

Reasons for withdrawal

Measure	Lithium Carbonate Add on Placebo Lithium started and then participants randomized to placebo	Lithium Carbonate Add on Valproate Lithium carbonate started and participants randomized to valproate
Overall Study Lost to Follow-up	6	7

Baseline Characteristics

Valproate Efficacy in Cocaine-Bipolar Comorbidity

Baseline characteristics by cohort

Measure	Lithium Carbonate Add on Placebo n=13 Participants Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo	Lithium Carbonate Add on Valproate n=13 Participants Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46.7 years STANDARD_DEVIATION 7.4 • n=5 Participants	44 years STANDARD_DEVIATION 7.7 • n=7 Participants	45.4 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: All subjects with available data after assignment to study medications

Change from baseline in percentage of self-report cocaine-abstinent (non-use) days (difference in base percent values)

Outcome measures

Measure	Lithium Carbonate Add on Placebo n=11 Participants Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo	Lithium Carbonate Add on Valproate n=12 Participants Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
Change From Baseline in Percentage of Cocaine-abstinent Days	16.4 percentage of days cocaine abstinent Standard Deviation 29.7	14.5 percentage of days cocaine abstinent Standard Deviation 20.3

SECONDARY outcome

Timeframe: week 12

Population: All subjects with available data after assignment to study medications

Change from baseline in percentage of the amount of money spent on cocaine

Outcome measures

Measure	Lithium Carbonate Add on Placebo n=11 Participants Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo	Lithium Carbonate Add on Valproate n=12 Participants Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
Change From Baseline in Percentage of Money Spent on Cocaine	-43.6 Percentage of Money Spent on Cocaine Standard Deviation 58.4	-34.9 Percentage of Money Spent on Cocaine Standard Deviation 56.1

Adverse Events

Lithium Carbonate Add on Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Lithium Carbonate Add on Valproate

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lithium Carbonate Add on Placebo n=13 participants at risk Lithium carbonate as standard treatment add on double blind placebo	Lithium Carbonate Add on Valproate n=13 participants at risk Lithium carbonate as standard treatment add on double blind valproate
Psychiatric disorders Hospitalization	0.00% 0/13	7.7% 1/13 • Number of events 1

Other adverse events

Measure	Lithium Carbonate Add on Placebo n=13 participants at risk Lithium carbonate as standard treatment add on double blind placebo	Lithium Carbonate Add on Valproate n=13 participants at risk Lithium carbonate as standard treatment add on double blind valproate
General disorders Headache	30.8% 4/13	23.1% 3/13
Cardiac disorders Heart palpatation	7.7% 1/13	7.7% 1/13
Gastrointestinal disorders Nausea, diarrhea	46.2% 6/13	46.2% 6/13
Renal and urinary disorders Increased urination	23.1% 3/13	23.1% 3/13
Musculoskeletal and connective tissue disorders Back wrist pain	23.1% 3/13	38.5% 5/13
Psychiatric disorders Restless, sleepless	30.8% 4/13	38.5% 5/13
General disorders Fall	0.00% 0/13	15.4% 2/13
Reproductive system and breast disorders sexual dysfunction	7.7% 1/13	7.7% 1/13
Reproductive system and breast disorders increased menses	7.7% 1/13	0.00% 0/13

Additional Information

Dr. Ihsan Salloum

Univeristy of Miami

Phone: 305-243-7931

Email: isalloum@med.miami.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place