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Induction with levomethadyl acetate: safety and efficacy
H E Jones1, E C Strain, G E Bigelow
1Department of Psychiatry and Behavioral Sciences, The Johns Hopkins University School of Medicine, Baltimore, MD 21224-6823, USA.
Background:
Levomethadyl acetate hydrochloride (known as LAAM) is a mu-opioid agonist approved for the treatment of opioid dependence. Clinical trials comparing LAAM and methadone have reported lower patient retention rates during LAAM induction; however, this may reflect dose and schedule differences. Few studies have systematically examined LAAM dose induction. This study compared induction with 3 different LAAM dosage levels.
Methods:
In a randomized, double-blind trial, male and female opioid-dependent patients (N = 180) were assigned to 1 of 3 LAAM doses. The low-dose (25 mg) induction was constant from the onset of treatment, the medium-dose (50 mg) induction lasted 7 days, and the high-dose (100 mg) induction lasted 17 days. Safety and efficacy were assessed on retention, urinalysis and self-reported drug use, symptoms, and patient ratings of medication adequacy.
Results:
The high-dose group had significantly fewer illicit opioid-positive urine samples in weeks 3 and 4 as compared with the low-dose group. The high-dose group had significantly lower self-reported heroin craving in weeks 2 and 3. All groups demonstrated significant decreases in illicit drug use, withdrawal symptoms, and depression. There were no between-group differences in retention; however, there was a trend (P = .08) for lower retention and a greater number of agonist adverse effects were observed in the high-dose group. Overall, LAAM doses were well tolerated by most patients.
Conclusion:
Induction with low and medium LAAM doses can be safely and effectively achieved within 7 days. Induction with higher LAAM doses can be safely achieved within 17 days, but may result in greater rates of patient dropout and opioid agonist adverse effects. Therefore, higher doses should be approached more slowly.
Insights
Levomethadyl acetate hydrochloride (LAAM) induction can be safely achieved within 7 days with low to medium doses. Higher LAAM doses require a slower 17-day induction to minimize adverse effects and potential dropout.
Area of Science:
- Pharmacology
- Addiction Medicine
- Clinical Trials
Background:
- Levomethadyl acetate hydrochloride (LAAM) is an approved mu-opioid agonist for opioid dependence treatment.
- Previous studies suggest lower retention rates with LAAM compared to methadone, potentially due to dosing differences.
- Systematic examination of LAAM induction dosing is limited.
Purpose of the Study:
- To compare the safety and efficacy of three different Levomethadyl acetate hydrochloride (LAAM) induction dosage levels.
- To evaluate the impact of varying LAAM induction schedules on patient outcomes.
Main Methods:
- A randomized, double-blind trial involving 180 opioid-dependent patients.
- Three LAAM induction groups: low-dose (25 mg constant), medium-dose (50 mg over 7 days), and high-dose (100 mg over 17 days).
- Assessment of safety and efficacy through retention rates, urinalysis, self-reported drug use, symptoms, and medication adequacy.
Main Results:
- The high-dose LAAM group showed significantly fewer illicit opioid-positive urines and lower self-reported heroin craving in early weeks.
- All groups achieved significant reductions in illicit drug use, withdrawal, and depression.
- No significant differences in retention, but a trend towards lower retention and more adverse effects in the high-dose group.
Conclusions:
- Low and medium LAAM doses can be safely and effectively induced within 7 days.
- Higher LAAM doses can be safely induced over 17 days, but may increase dropout and adverse effects.
- Slower induction is recommended for higher LAAM doses to improve patient tolerance and retention.