Citalopram for Cocaine Dependence

• Sponsor: Joy Schmitz (Other)
• Overall Status: Completed
• CT.gov ID: NCT01535573
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 108
• Location: 1
• Arms: 3
• Duration (Months): 67
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Dependence	Drug: Citalopram; Drug: Citalopram; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Clinical Trial of Serotonin Medication Combination in Cocaine Dependence
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Citalopram low dose Citalopram 20 mg	Drug: Citalopram; 20 mg once per day for 9 weeks
Active Comparator: Citalopram high dose Citalopram 40 mg	Drug: Citalopram; 40 mg per day for 9 weeks
Placebo Comparator: Placebo Placebo	Drug: Placebo; 0 mg per day for 9 weeks

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test [9 weeks]

   Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.

Secondary Outcome Measures

1. Proportion of Cocaine-positive Urines Per Week [9 weeks]

   Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use.

2. Number of Participants With Cocaine-negative Urines Collected During Treatment Period [9 weeks]

   Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.

3. Retention as Assessed by Number of Participants Remaining in Treatment [9 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• between 18 and 60 years of age

• meet Diagnostic and Statistical Manual 4 (DSM-IV) criteria for current cocaine dependence

• be in acceptable health on the basis of interview, medical history and physical exam

• able to provide the names of at least 2 persons who can generally locate their whereabouts.

Exclusion Criteria:

• diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine

• have a psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe

• medical conditions contraindicating citalopram pharmacotherapy

• taking medications known to have significant drug interactions with the study medication

• pregnant or nursing for female patients

• having plans to leave the immediate geographical area within 3 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT-Houston Behavioral and Biomedical Sciences Building	Houston	Texas	United States	77054

Sponsors and Collaborators

• Joy Schmitz
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Joy M Schmitz, Ph.D., University of Texas at Houston

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joy Schmitz, Professor , Behavioral Sciences, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT01535573
• Other Study ID Numbers: 2P50DA009262-16A1; 2P50DA009262-16A1
• First Posted: Feb 17, 2012
• Last Update Posted: Sep 16, 2020
• Last Verified: Aug 1, 2020

• Keywords provided by Joy Schmitz, Professor , Behavioral Sciences, The University of Texas Health Science Center, Houston: Cocaine; citalopram; treatment; serotonin
• Additional relevant MeSH terms: Cocaine-Related Disorders; Dexetimide; Citalopram

Study Results

Participant Flow

Arm/Group Title	Citalopram Low Dose	Citalopram High Dose	Placebo
Arm/Group Description	Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks	Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks	Placebo Placebo: 0 mg per day for 9 weeks
Period Title: Overall Study
STARTED	21	44	43
COMPLETED	13	23	24
NOT COMPLETED	8	21	19

Baseline Characteristics

Arm/Group Title	Citalopram Low Dose	Citalopram High Dose	Placebo	Total
Arm/Group Description	Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks	Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks	Placebo Placebo: 0 mg per day for 9 weeks	Total of all reporting groups
Overall Participants	21	44	43	108
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.905 (7.578)	44.477 (9.488)	47.116 (8.724)	46.000 (8.846)
Sex: Female, Male (Count of Participants)
Female	3 14.3%	8 18.2%	8 18.6%	19 17.6%
Male	18 85.7%	36 81.8%	35 81.4%	89 82.4%
Race/Ethnicity, Customized (Count of Participants)
American Indian or Alaskan Native	0 0%	1 2.3%	0 0%	1 0.9%
Black or African American	18 85.7%	32 72.7%	31 72.1%	81 75%
Hispanic	2 9.5%	5 11.4%	5 11.6%	12 11.1%
White	1 4.8%	6 13.6%	7 16.3%	14 13%
Region of Enrollment (participants) [Number]
United States	21 100%	44 100%	43 100%	108 100%
Number of Years of Education (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.571 (2.216)	12.045 (1.796)	12.488 (1.921)	12.324 (1.932)
Number of Days of Cocaine Use in Past 30 Days (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	12.238 (2.216)	17.114 (9.163)	14.465 (9.815)	15.111 (8.594)

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test
Description	Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Citalopram Low Dose	Citalopram High Dose	Placebo
Arm/Group Description	Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks	Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks	Placebo Placebo: 0 mg per day for 9 weeks
Measure Participants	21	44	43
Count of Participants [Participants]	0 0%	4 9.1%	2 4.7%

2. Secondary Outcome

Title	Proportion of Cocaine-positive Urines Per Week
Description	Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use.
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Citalopram Low Dose	Citalopram High Dose	Placebo
Arm/Group Description	Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks	Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks	Placebo Placebo: 0 mg per day for 9 weeks
Measure Participants	21	44	43
Mean (Standard Deviation) [proportion of cocaine urines per week]	0.85 (0.23)	0.8 (0.3)	0.85 (0.25)

3. Secondary Outcome

Title	Number of Participants With Cocaine-negative Urines Collected During Treatment Period
Description	Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use.
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Citalopram Low Dose	Citalopram High Dose	Placebo
Arm/Group Description	Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks	Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks	Placebo Placebo: 0 mg per day for 9 weeks
Measure Participants	21	44	43
Count of Participants [Participants]	14 66.7%	26 59.1%	27 62.8%

4. Secondary Outcome

Title	Retention as Assessed by Number of Participants Remaining in Treatment
Time Frame	9 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Citalopram Low Dose	Citalopram High Dose	Placebo
Arm/Group Description	Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks	Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks	Placebo Placebo: 0 mg per day for 9 weeks
Measure Participants	21	44	43
Count of Participants [Participants]	13 61.9%	23 52.3%	24 55.8%

Adverse Events

Time Frame	9 weeks
Arm/Group Title	Citalopram Low Dose		Citalopram High Dose		Placebo
Arm/Group Description	Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks		Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks		Placebo Placebo: 0 mg per day for 9 weeks
All Cause Mortality
	Citalopram Low Dose		Citalopram High Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/44 (0%)		0/43 (0%)
Serious Adverse Events
	Citalopram Low Dose		Citalopram High Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/44 (0%)		1/43 (2.3%)
Psychiatric disorders
Hospitalization for Suicidal Ideation	0/21 (0%)	0	0/44 (0%)	0	1/43 (2.3%)	1
Other (Not Including Serious) Adverse Events
	Citalopram Low Dose		Citalopram High Dose		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/21 (42.9%)		20/44 (45.5%)		10/43 (23.3%)
Cardiac disorders
Elevated Blood Pressure	0/21 (0%)	0	0/44 (0%)	0	1/43 (2.3%)	1
Abnormal electrocardiogram (EKG)	0/21 (0%)	0	1/44 (2.3%)	1	0/43 (0%)	0
Eye disorders
Blurry Vision	0/21 (0%)	0	1/44 (2.3%)	1	0/43 (0%)	0
Gastrointestinal disorders
Diarrhea	0/21 (0%)	0	2/44 (4.5%)	2	1/43 (2.3%)	1
General disorders
Drowsiness	0/21 (0%)	0	1/44 (2.3%)	1	0/43 (0%)	0
Not Sleeping Well	2/21 (9.5%)	2	1/44 (2.3%)	4	4/43 (9.3%)	8
Headache	0/21 (0%)	0	2/44 (4.5%)	2	0/43 (0%)	0
Nervousness	0/21 (0%)	0	0/44 (0%)	0	1/43 (2.3%)	1
Change in Sexual Function	0/21 (0%)	0	2/44 (4.5%)	3	0/43 (0%)	0
Sweating	1/21 (4.8%)	1	2/44 (4.5%)	2	0/43 (0%)	0
Fatigue	1/21 (4.8%)	1	1/44 (2.3%)	1	0/43 (0%)	0
Loss of Appetite	1/21 (4.8%)	1	4/44 (9.1%)	6	0/43 (0%)	0
Confusion	0/21 (0%)	0	1/44 (2.3%)	1	0/43 (0%)	0
Musculoskeletal and connective tissue disorders
Difficulty Walking	1/21 (4.8%)	2	1/44 (2.3%)	1	0/43 (0%)	0
Renal and urinary disorders
Increased Urination	2/21 (9.5%)	2	0/44 (0%)	0	0/43 (0%)	0
Respiratory, thoracic and mediastinal disorders
Shortness of Breath	0/21 (0%)	0	0/44 (0%)	0	1/43 (2.3%)	1
Cough	1/21 (4.8%)	1	1/44 (2.3%)	1	2/43 (4.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.