Trial Outcomes & Findings for A Pilot Study of Candesartan as a Treatment for Cocaine Dependence (NCT NCT01938664)

NCT ID: NCT01938664

Last Updated: 2019-09-04

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: thrice weekly, baseline thru week 8
• Results posted on: 2019-09-04

Participant Flow

Participant milestones

Measure	Candesartan w Cognitive Behavior Therapy Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study. Candesartan with CBT: 8 mg, po (by mouth)	Placebo w Cognitive Behavior Therapy Sugar pill to mimic Candesartan for study duration. CBT optional thru study. Placebo with CBT
Overall Study STARTED	20	10
Overall Study COMPLETED	5	0
Overall Study NOT COMPLETED	15	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study of Candesartan as a Treatment for Cocaine Dependence

Baseline characteristics by cohort

Measure	Candesartan w Cognitive Behavior Therapy n=20 Participants Titration up to 8mg wk 1-4. Continue on 8mg thru wk 8. CBT optional thru study. Candesartan with CBT: 8 mg, po (by mouth)	Placebo w Cognitive Behavior Therapy n=10 Participants Sugar pill to mimic Candesartan for study duration. CBT optional thru study. Placebo with CBT	Total n=30 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	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: thrice weekly, baseline thru week 8

Outcome measures

Measure	Candesartan w Cognitive Behavior Therapy n=20 Participants Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study. Candesartan with CBT: 8 mg, po (by mouth)	Placebo w Cognitive Behavior Therapy n=10 Participants Sugar pill to mimic Candesartan for study duration. CBT optional thru study. Placebo with CBT
# of Participants With Presence of Cocaine Metabolites Via Urinalysis	20 participants	10 participants

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Measure	Candesartan w Cognitive Behavior Therapy n=20 Participants Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study. Candesartan with CBT: 8 mg, po (by mouth)	Placebo w Cognitive Behavior Therapy n=10 Participants Sugar pill to mimic Candesartan for study duration. CBT optional thru study. Placebo with CBT
# of Participants Retained in Study	5 participants	0 participants

SECONDARY outcome

Timeframe: 8 weeks

Candesartan will be well tolerated without significant side effects.

Outcome measures

Measure	Candesartan w Cognitive Behavior Therapy n=20 Participants Titration up to 8mg through week 1. Continue on 8mg thru wk 8. CBT optional thru study. Candesartan with CBT: 8 mg, po (by mouth)	Placebo w Cognitive Behavior Therapy n=10 Participants Sugar pill to mimic Candesartan for study duration. CBT optional thru study. Placebo with CBT
# of Participants With Adverse Events	0 participants	0 participants

Adverse Events

Candesartan w Cognitive Behavior Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo w Cognitive Behavior Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Thomas Kosten, MD

Baylor College of Medicine

Phone: 713-794-7032

Email: kosten@bcm.edu

Results disclosure agreements

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