Trial Outcomes & Findings for A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence (NCT NCT00421603)

Last Updated: 2019-04-24

Results Overview

Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period by the Time Line Follow Back. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

3 weeks of abstinence during 14 weeks of trial or for length of participation

Results posted on

2019-04-24

Participant Flow

Participants were recruited by local advertising (internet, print, radio, television, and subway) or by clinical referrals in the New York City metropolitan area between January 2007 and February 2010.

Prior to group assignment patients participated in a one week placebo lead-in.

Participant milestones

Participant milestones
Measure	Adderall-XR and Topiramate Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.	Placebo Placebo daily dose
Overall Study STARTED	39	42
Overall Study COMPLETED	28	30
Overall Study NOT COMPLETED	11	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adderall-XR and Topiramate n=39 Participants Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.	Placebo n=42 Participants Placebo daily dose	Total n=81 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	39 Participants n=5 Participants	42 Participants n=7 Participants	81 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	41.5 years STANDARD_DEVIATION 8.2 • n=5 Participants	42.4 years STANDARD_DEVIATION 8.9 • n=7 Participants	42.1 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	37 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	42 participants n=7 Participants	81 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks of abstinence during 14 weeks of trial or for length of participation

Outcome measures

Outcome measures
Measure	Adderall-XR and Topiramate n=39 Participants Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.	Placebo n=42 Participants Placebo daily dose
Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back	13 participants	7 participants

Adverse Events

Adderall-XR and Topiramate

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Adderall-XR and Topiramate n=39 participants at risk Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.	Placebo n=42 participants at risk Placebo daily dose
Psychiatric disorders substance-induced mood syndrome	2.6% 1/39 • Number of events 1 • during 14 weeks of trial or length of participants participation	0.00% 0/42 • during 14 weeks of trial or length of participants participation
Psychiatric disorders residential drug treatment	0.00% 0/39 • during 14 weeks of trial or length of participants participation	2.4% 1/42 • Number of events 1 • during 14 weeks of trial or length of participants participation

Other adverse events

Other adverse events
Measure	Adderall-XR and Topiramate n=39 participants at risk Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.	Placebo n=42 participants at risk Placebo daily dose
Psychiatric disorders Insomnia	41.0% 16/39 • Number of events 16 • during 14 weeks of trial or length of participants participation	16.7% 7/42 • Number of events 7 • during 14 weeks of trial or length of participants participation
Metabolism and nutrition disorders Increased/decreased appetite	43.6% 17/39 • Number of events 17 • during 14 weeks of trial or length of participants participation	9.5% 4/42 • Number of events 4 • during 14 weeks of trial or length of participants participation
General disorders Fatigue	28.2% 11/39 • Number of events 11 • during 14 weeks of trial or length of participants participation	14.3% 6/42 • Number of events 6 • during 14 weeks of trial or length of participants participation
Gastrointestinal disorders GI upset	28.2% 11/39 • Number of events 11 • during 14 weeks of trial or length of participants participation	11.9% 5/42 • Number of events 5 • during 14 weeks of trial or length of participants participation
General disorders Headache	28.2% 11/39 • Number of events 11 • during 14 weeks of trial or length of participants participation	11.9% 5/42 • Number of events 5 • during 14 weeks of trial or length of participants participation
Gastrointestinal disorders Nausea	25.6% 10/39 • Number of events 10 • during 14 weeks of trial or length of participants participation	9.5% 4/42 • Number of events 4 • during 14 weeks of trial or length of participants participation
General disorders Dizziness	25.6% 10/39 • Number of events 10 • during 14 weeks of trial or length of participants participation	9.5% 4/42 • Number of events 4 • during 14 weeks of trial or length of participants participation
Psychiatric disorders Anxiety	23.1% 9/39 • Number of events 9 • during 14 weeks of trial or length of participants participation	2.4% 1/42 • Number of events 1 • during 14 weeks of trial or length of participants participation
Nervous system disorders Paresthesia	23.1% 9/39 • Number of events 9 • during 14 weeks of trial or length of participants participation	2.4% 1/42 • Number of events 1 • during 14 weeks of trial or length of participants participation
General disorders Irritable	20.5% 8/39 • Number of events 8 • during 14 weeks of trial or length of participants participation	4.8% 2/42 • Number of events 2 • during 14 weeks of trial or length of participants participation

Additional Information

Daniel Brooks

NYSPI

Phone: 212-740-3205

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place