Methamphetamine Dependence
Conditions
Brief summary
This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.
Interventions
DRUGModafinil
subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7
Sponsors
National Institute on Drug Abuse (NIDA)
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-65 years old * not currently enrolled in a treatment program * subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry * subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID) * women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study
Exclusion criteria
* current diagnosis of alcohol, opiate, or sedative physical dependence * ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder) * history of schizophrenia, or bipolar type I disorder * present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested * medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine, or desipramine) * Current suicidality or psychosis * liver function tests (i.e., liver enzymes) greater than three times normal levels * pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure | Thrice weekly for 7 weeks | Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg. |
| Heart Rate | Thrice weekly for 7 weeks | Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute. |
| Systolic Blood Pressure | Thrice weekly for 7 weeks | Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg. |
| Depression as Measured by the Hamilton Depression Scale | Thrice weekly for 7 weeks | 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. |
| Modafinil Side Effects Checklist | Weekly for 7 weeks | 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. |
| Anxiety as Measured by the Hamilton Anxiety Scale | Thrice weekly for 7 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire. | Thrice weekly for the first three weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Modafinil All participants were started on Modafinil titrated to 400mg in this open label trial. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Modafinil |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age Continuous | 45.3 years STANDARD_DEVIATION 7.2 |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Anxiety as Measured by the Hamilton Anxiety Scale
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil | Anxiety as Measured by the Hamilton Anxiety Scale | 4.07 units on a scale | Standard Deviation 2.44 |
Primary
Depression as Measured by the Hamilton Depression Scale
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil | Depression as Measured by the Hamilton Depression Scale | 5.64 units on a scale | Standard Deviation 3.41 |
Primary
Diastolic Blood Pressure
Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil | Diastolic Blood Pressure | 81.49 mmHg | Standard Deviation 2.67 |
Primary
Heart Rate
Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil | Heart Rate | 79.66 beats per minute | Standard Deviation 2.22 |
Primary
Modafinil Side Effects Checklist
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil | Modafinil Side Effects Checklist | 3.75 units on a scale | Standard Deviation 2.94 |
Primary
Systolic Blood Pressure
Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil | Systolic Blood Pressure | 128.62 mmHg | Standard Deviation 3.15 |
Secondary
Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.
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.
Time frame: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modafinil | Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire. | 5.79 units on a scale | Standard Deviation 4.42 |