Trial Outcomes & Findings for Quetiapine for the Reduction of Cocaine Use (NCT NCT00631748)

Last Updated: 2014-03-31

Results Overview

The primary outcome measure was the self-report of cocaine use in the past week, as assessed with a Timeline Followback Interview (TLFB). The TLFB is a questionnaire in which the subject is asked to self-report how much cocaine was used and how much money was spent on cocaine every day for the past 1-2 weeks.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Grams of cocaine used at end of study (12-weeks)

Results posted on

2014-03-31

Participant Flow

Participants with a diagnosis of cocaine dependence were recruited from the VA Puget Sound Health Care System and the local community.

A screening visit was conducted to ensure that they met inclusion/exclusion criteria for the study. If they met criteria, they were scheduled for a baseline visit, during which they were randomized to either the quetiapine or placebo arm of the study.

Participant milestones

Participant milestones
Measure	Study Drug Oral quetiapine	Placebo Placebo (sugar pill)
Overall Study STARTED	29	31
Overall Study COMPLETED	11	9
Overall Study NOT COMPLETED	18	22

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Quetiapine for the Reduction of Cocaine Use

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Drug n=29 Participants Oral quetiapine	Placebo n=31 Participants Placebo (sugar pill)	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=93 Participants	31 Participants n=4 Participants	60 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	48.11 years STANDARD_DEVIATION 6.97 • n=93 Participants	47.71 years STANDARD_DEVIATION 9.69 • n=4 Participants	47.90 years STANDARD_DEVIATION 8.38 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Sex: Female, Male Male	26 Participants n=93 Participants	26 Participants n=4 Participants	52 Participants n=27 Participants
Region of Enrollment United States	29 participants n=93 Participants	31 participants n=4 Participants	60 participants n=27 Participants

PRIMARY outcome

Timeframe: Grams of cocaine used at end of study (12-weeks)

Population: At end of study(12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.

Outcome measures

Outcome measures
Measure	Study Drug n=11 Participants Quetiapine (Seroquel XR)	Placebo n=9 Participants matched placebo (sugar pill)
Timeline Followback Interview (TLFB)	0.11 grams of cocaine used Standard Deviation 0.30	0.63 grams of cocaine used Standard Deviation 1.78

SECONDARY outcome

Timeframe: Abstinence defined as negative UDS for 3 consecutive weeks of the trial

Population: At end of study (12-weeks) 11 participants remained in the quetiapine group and 9 participants remained in the placebo group.

Abstinence was defined as a negative urine drug screen (UDS) (for cocaine) for three consecutive weeks of the trial measure at either time point Week 6 or Week 12

Outcome measures

Outcome measures
Measure	Study Drug n=11 Participants Quetiapine (Seroquel XR)	Placebo n=9 Participants matched placebo (sugar pill)
Percentage of Participants Attaining Abstinence for Three Weeks	45.5 Percentage of Participants	44.4 Percentage of Participants

Adverse Events

Study Drug

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Study Drug n=29 participants at risk Oral quetiapine	Placebo n=31 participants at risk Placebo (sugar pill)
Respiratory, thoracic and mediastinal disorders Respitory distress	3.4% 1/29 • Number of events 1 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	0.00% 0/31 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Psychiatric disorders Suicidal ideation	0.00% 0/29 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	3.2% 1/31 • Number of events 1 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.

Other adverse events

Additional Information

Andre Tapp, MD

VA Puget Sound Health Care System

Phone: 253-589-4176

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Study Drug n=29 participants at risk Oral quetiapine	Placebo n=31 participants at risk Placebo (sugar pill)
Psychiatric disorders Akathesia	31.0% 9/29 • Number of events 10 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	6.5% 2/31 • Number of events 2 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Musculoskeletal and connective tissue disorders Back Pain	3.4% 1/29 • Number of events 1 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	16.1% 5/31 • Number of events 5 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Gastrointestinal disorders Constipation	17.2% 5/29 • Number of events 5 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	25.8% 8/31 • Number of events 8 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Ear and labyrinth disorders Dizziness/Lightheadedness	3.4% 1/29 • Number of events 1 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	12.9% 4/31 • Number of events 4 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
General disorders Drowsiness/Hypersomnia	58.6% 17/29 • Number of events 17 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	32.3% 10/31 • Number of events 10 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
General disorders Dry Mouth	58.6% 17/29 • Number of events 17 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	19.4% 6/31 • Number of events 6 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Gastrointestinal disorders Heartburn	6.9% 2/29 • Number of events 2 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	0.00% 0/31 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Renal and urinary disorders Incontinence	3.4% 1/29 • Number of events 1 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	9.7% 3/31 • Number of events 3 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Metabolism and nutrition disorders Increased Appetitie	17.2% 5/29 • Number of events 5 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	6.5% 2/31 • Number of events 2 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
General disorders Insomnia	34.5% 10/29 • Number of events 10 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	35.5% 11/31 • Number of events 11 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Reproductive system and breast disorders Menstral Irregularities	6.9% 2/29 • Number of events 2 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	3.2% 1/31 • Number of events 1 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Vascular disorders Orthostasis	17.2% 5/29 • Number of events 5 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	12.9% 4/31 • Number of events 4 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Skin and subcutaneous tissue disorders Skin Rash	6.9% 2/29 • Number of events 2 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	12.9% 4/31 • Number of events 4 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Renal and urinary disorders Urinary Hesitancy	10.3% 3/29 • Number of events 3 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	9.7% 3/31 • Number of events 3 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
General disorders Weight Gain	27.6% 8/29 • Number of events 8 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	6.5% 2/31 • Number of events 2 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.
Reproductive system and breast disorders Sexual Dysfunction	27.6% 8/29 • Number of events 8 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.	12.9% 4/31 • Number of events 4 • Adverse events were collected during the entire time the subject was enrolled in the study, including the screening, 12-week clinical trial, and 4 week follow-up appointment.