Amphetamine Dependence
Conditions
Keywords
amphetamine dependence, amphetamine injection, VIVITROL/VIVITROL placebo, amphetamine craving
Brief summary
Until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. The primary aim of this pilot study is to replicate the findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable suspension) or VIVITROL placebo. Patients in each group will receive drug counseling. VIVITROL is administered monthly and may be a better test of efficacy than tablets that must be taken daily.
Interventions
DRUGVIVITROL injection and VIVITROL Placebo Injection , 24 weeks
Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
Sponsors
National Institute on Drug Abuse (NIDA)
Society of Alcoholism and other Addictions
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or above; 2. Diagnosis of amphetamine dependence as defined by DSM-IV-TR with 10 or more days of amphetamine use in the past month, and patient and clinician identify amphetamine dependence as the main problem; 3. Abstinent from substances (alcohol, amphetamines, cannabinoid, cocaine, hallucinogens, opioids, benzodiazepines \[unless used to treat alcohol withdrawal\] for at least 7 days prior to receiving study drug or placebo; 4. Provision of telephone numbers/contacts of three or more people that are likely to know where can be located if unable to be contacted directly; 5. Successfully complete 7-10 day assessment and study baseline measures at Vogur
Exclusion criteria
1. Any liver test \>5 times the top limit of normal; Physiologically dependent on opioids or other substances (nicotine excepted) at time of admission to Vogur; 2. Suspected or known concomitant use of opioid analgesics, positive opioid urine drug test or positive naloxone challenge: 3. Schizophrenia, Bipolar I or other non-substance related psychotic disorder; Severely depressed, suicidal or homicidal: Dementia: Inability to understand the informed consent; 4. Planning to move from the Reykjavík area or enter jail within the next 12 months; 5. Likely to receive opioid analgesics in next 6 months associated with possible or scheduled surgery or procedure; 6. Known hypersensitivity to naltrexone, polyactide-co-glycolide (PLG); carboxymethylcellulose, or any other component of the diluent; 7. Female subjects who are pregnant or lactating, or of child bearing potential who are not using acceptable methods of birth control; 8. A body habitus that precludes use of the customized needle for intramuscular injection, based on clinical judgment; 9. Use of an investigational agent in the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number Negative Urines (Proportion Negative Urines) | 24 Weeks |
| Number Negative Urines (Proportion Negative Urines) Amphetamine | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amphetamine Craving Scale | 24 weeks | The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100. |
| Beck Depression Inventory | 24 weeks | The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms. |
| Risk Assessment Battery | 24 weeks | The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1. |
| Prior Admissions to Vogur Hospital | Baseline | Number of prior admissions due to substance dependence. The term prior admissions refers to admissions before enrollment, thus Baseline is the appropriate Time Frame. |
Countries
Iceland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VIVITROL Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) | 51 |
| VIVITROL Placebo Injection, 24 Weeks Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) | 49 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 6 |
| Overall Study | Received <4 study injections | 10 | 13 |
| Overall Study | Withdrawal by Subject | 6 | 4 |
Baseline characteristics
| Characteristic | VIVITROL Placebo Injection, 24 Weeks | VIVITROL Injection, 24 Weeks | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 49 Participants | 51 Participants | 100 Participants |
| Age, Continuous | 31.59 years STANDARD_DEVIATION 1.34 | 31.51 years STANDARD_DEVIATION 1.11 | 31.55 years STANDARD_DEVIATION 1 |
| Region of Enrollment Iceland | 49 participants | 51 participants | 100 participants |
| Sex: Female, Male Female | 10 Participants | 15 Participants | 25 Participants |
| Sex: Female, Male Male | 39 Participants | 36 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 51 | 27 / 49 |
| serious Total, serious adverse events | 9 / 51 | 7 / 49 |
Outcome results
Primary
Number Negative Urines (Proportion Negative Urines)
Time frame: 24 Weeks
Population: Urine drug screens negative amphetamine
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIVITROL Injection, 24 Weeks | Number Negative Urines (Proportion Negative Urines) | 560 Urine Drug Screen |
| VIVITROL Placebo Injection, 24 Weeks | Number Negative Urines (Proportion Negative Urines) | 634 Urine Drug Screen |
Primary
Number Negative Urines (Proportion Negative Urines) Amphetamine
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIVITROL Injection, 24 Weeks | Number Negative Urines (Proportion Negative Urines) Amphetamine | 560 Urine Drug Screen |
| VIVITROL Placebo Injection, 24 Weeks | Number Negative Urines (Proportion Negative Urines) Amphetamine | 634 Urine Drug Screen |
Secondary
Amphetamine Craving Scale
The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIVITROL Injection, 24 Weeks | Amphetamine Craving Scale | 40.9 VAS Score | Standard Deviation 4 |
| VIVITROL Placebo Injection, 24 Weeks | Amphetamine Craving Scale | 46.92 VAS Score | Standard Deviation 4.38 |
Secondary
Beck Depression Inventory
The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIVITROL Injection, 24 Weeks | Beck Depression Inventory | 14.63 BDI Score | Standard Deviation 1.4 |
| VIVITROL Placebo Injection, 24 Weeks | Beck Depression Inventory | 14.08 BDI Score | Standard Deviation 1.09 |
Secondary
Prior Admissions to Vogur Hospital
Number of prior admissions due to substance dependence. The term prior admissions refers to admissions before enrollment, thus Baseline is the appropriate Time Frame.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIVITROL Injection, 24 Weeks | Prior Admissions to Vogur Hospital | 5.78 Number of admissions | Standard Deviation 0.87 |
| VIVITROL Placebo Injection, 24 Weeks | Prior Admissions to Vogur Hospital | 4.88 Number of admissions | Standard Deviation 0.63 |
Secondary
Risk Assessment Battery
The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VIVITROL Injection, 24 Weeks | Risk Assessment Battery | 7.14 Total Score | Standard Deviation 0.62 |
| VIVITROL Placebo Injection, 24 Weeks | Risk Assessment Battery | 5.98 Total Score | Standard Deviation 0.43 |