Trial Outcomes & Findings for Safety and Tolerability of Modafinil for Methamphetamine Dependence (NCT NCT00569374)

Results Overview

Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Thrice weekly for 7 weeks

Results posted on

2010-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Modafinil All participants were started on Modafinil titrated to 400mg in this open label trial.
Overall Study STARTED	8
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Modafinil All participants were started on Modafinil titrated to 400mg in this open label trial.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Safety and Tolerability of Modafinil for Methamphetamine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modafinil n=8 Participants All participants were started on Modafinil titrated to 400mg in this open label trial.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	45.3 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Thrice weekly for 7 weeks

Population: The data reported was obtained by computing the overall mean heart rate for each participant, then using these to compute the overall mean.

Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.

Outcome measures

Outcome measures
Measure	Modafinil n=8 Participants All participants were started on Modafinil titrated to 400mg in this open label trial.
Heart Rate	79.66 beats per minute Standard Deviation 2.22

PRIMARY outcome

Timeframe: Thrice weekly for 7 weeks

Population: The data reported was obtained by computing the overall mean systolic blood pressure for each participant, then using these to compute the overall mean.

Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.

Outcome measures

Outcome measures
Measure	Modafinil n=8 Participants All participants were started on Modafinil titrated to 400mg in this open label trial.
Systolic Blood Pressure	128.62 mmHg Standard Deviation 3.15

PRIMARY outcome

Timeframe: Thrice weekly for 7 weeks

Population: The data reported was obtained by computing the overall mean diastolic blood pressure for each participant, then using these to compute the overall mean.

Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.

Outcome measures

Outcome measures
Measure	Modafinil n=8 Participants All participants were started on Modafinil titrated to 400mg in this open label trial.
Diastolic Blood Pressure	81.49 mmHg Standard Deviation 2.67

PRIMARY outcome

Timeframe: Weekly for 7 weeks

Population: The data reported was obtainined by computing the overall mean numberical score on the Modafinil Side Effects Checklist for each participant, then using these to compute the overall mean. The checklist is a 10 item scale with each item scoring between 0 (none) to 4 (worst). The potential scores range from 0 (least) to 40 (worst).

Modafinil side effects were measured weekly by means of the Modafinil Side Effects Checklist which asked participants to rate their experience of the following potential side effects: headaches, nausea, nervousness, runny nose, diarrhea, back pain, anxiety, insomnia, dizziness and upset stomach. Participants rated their experience on a 4 point scale ranging from "not at all" (0) to "very much (4). The score was determined by units on a scale.

Outcome measures

Outcome measures
Measure	Modafinil n=8 Participants All participants were started on Modafinil titrated to 400mg in this open label trial.
"Modafinil Side Effects Checklist"	3.75 units on a scale Standard Deviation 2.94

PRIMARY outcome

Timeframe: Thrice weekly for 7 weeks

Population: The data reported was obtained by computing the overall mean score on the Hamilton Anxiety Scale for each participant, then using these to compute the overall mean. The scale is a 14 item instrument with each item scoring a potential range of 0 (none) to 4 (worst). The potential total scores range form 0 (least) to 56 (worst).

Participants were administered the Hamilton Anxiety Scale thrice weekly throughout the study. The scale is a 14 item questionaire with scores ranging from 0 to 56.

Outcome measures

Outcome measures
Measure	Modafinil n=8 Participants All participants were started on Modafinil titrated to 400mg in this open label trial.
Anxiety as Measured by the Hamilton Anxiety Scale	4.07 units on a scale Standard Deviation 2.44

PRIMARY outcome

Timeframe: Thrice weekly for 7 weeks

Population: The data reported was obtained by computing the overall mean score on the Hamilton Depression Scale for each participant, then using these to compute the overall mean. It is a 22 item scale of which 13 items have a score of 0 (none) to 4 (worst) and 9 have a score of 0 (none) to 2 (worst). The total score ranges from 0 (least) to 70 (worst).

Participants were administered the Hamilton Depression Scale thrice weekly throughout the study. The scale is a 21 item questionaire with scores ranging from 0 to 62 with a cutoff for depression of 15.

Outcome measures

Outcome measures
Measure	Modafinil n=8 Participants All participants were started on Modafinil titrated to 400mg in this open label trial.
Depression as Measured by the Hamilton Depression Scale	5.64 units on a scale Standard Deviation 3.41

SECONDARY outcome

Timeframe: Thrice weekly for the first three weeks

Population: The data reported was obtained by computing the overall mean numerical score on the Amphetamine Withdrawal Questionaire for each participant, then using these to compute the overall mean. The scale consists of 13 items ranging from 0 (none) to 4 (worst). The total score ranges from 0 (least) to 52 (worst).

The Amphetamine Withdrawal Questionaire was given at intake and 3 times weekly during the first 3 weeks of the study. This time span was chosen due to the tendency of methamphetamine withdrawal to enter an acute phase in the first week after last use with a subsequent subacute phase following for the next two weeks(McGregor et al, 2005). This questionaire is comprised of 10 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score is 0 and the maximum score is 40.

Outcome measures

Outcome measures
Measure	Modafinil n=8 Participants All participants were started on Modafinil titrated to 400mg in this open label trial.
Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.	5.79 units on a scale Standard Deviation 4.42

Adverse Events

Modafinil

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Modafinil n=8 participants at risk All participants were started on Modafinil titrated to 400mg in this open label trial.
General disorders Tachycardia	12.5% 1/8 • Number of events 1 • These results were collected over a period of 1 year and 10 months. Five Adverse events occurred during the study, of which three were probably related to study participation. Adverse events included one report each of tachycardia and dry mouth. The third occurred when a subject missed a dose on one day and took a double dose the next day. The subject experienced tachycardia, dry mouth, nervousness which resolved within one hour of modafinil ingestion.
General disorders Dry mouth	12.5% 1/8 • Number of events 1 • These results were collected over a period of 1 year and 10 months. Five Adverse events occurred during the study, of which three were probably related to study participation. Adverse events included one report each of tachycardia and dry mouth. The third occurred when a subject missed a dose on one day and took a double dose the next day. The subject experienced tachycardia, dry mouth, nervousness which resolved within one hour of modafinil ingestion.
General disorders Tachycardia, dry mouth, nervousness after taking extra dose	12.5% 1/8 • Number of events 1 • These results were collected over a period of 1 year and 10 months. Five Adverse events occurred during the study, of which three were probably related to study participation. Adverse events included one report each of tachycardia and dry mouth. The third occurred when a subject missed a dose on one day and took a double dose the next day. The subject experienced tachycardia, dry mouth, nervousness which resolved within one hour of modafinil ingestion.

Additional Information

Dr. Alison Oliveto

University of Arkansas for Medical Sciences Center for Addiction Research

Phone: 501-526-8441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place