Original Article

Asics Black Gel Saffety Yellow Trainers Yellow Lyte Adults' Speed 0790 Unisex 1frq1w6x

  • Paul J. Fudala, Ph.D.,
  • Lyte Asics Trainers Yellow Unisex Yellow Gel Speed 0790 Black Saffety Adults' T. Peter Bridge, M.D.,
  • Susan Herbert, M.A.,
  • William O. Williford, Ph.D.,
  • C. Nora Chiang, Ph.D.,
  • Karen Jones, M.S.,
  • Joseph Collins, Sc.D.,
  • Dennis Raisch, Ph.D.,
  • Paul Casadonte, M.D.,
  • R. Jeffrey Goldsmith, M.D.,
  • Walter Ling, M.D.,
  • Usha Malkerneker, M.D.,
  • Laura McNicholas, M.D., Ph.D.,
  • John Renner, M.D.,
  • Susan Stine, M.D., Ph.D.,
  • and Donald Tusel, M.D.
  • for the Buprenorphine/Naloxone Collaborative Study GroupMaxi Blue Multi Trap Flower Dress Women's Print Ribbon with Detail JOA vzwtFqy

Abstract

Background

Office-based treatment of opiate addiction with a sublingual-tablet formulation of buprenorphine and naloxone has been proposed, but its efficacy and safety have not been well studied.

Methods

We conducted a multicenter, randomized, placebo-controlled trial involving 326 opiate-addicted persons who were assigned to office-based treatment with sublingual tablets consisting of buprenorphine (16 mg) in combination with naloxone (4 mg), buprenorphine alone (16 mg), or placebo given daily for four weeks. The primary outcome measures were the percentage of urine samples negative for opiates and the subjects' self-reported craving for opiates. Safety data were obtained on 461 opiate-addicted persons who participated in an open-label study of buprenorphine and naloxone (at daily doses of up to 24 mg and 6 mg, respectively) and another 11 persons who received this combination only during the trial.

Results

The double-blind trial was terminated early because buprenorphine and naloxone in combination and buprenorphine alone were found to have greater efficacy than placebo. The proportion of urine samples that were negative for opiates was greater in the combined-treatment and buprenorphine groups (17.8 percent and 20.7 percent, respectively) than in the placebo group (5.8 percent, P<0.001 for both comparisons); the active-treatment groups also reported less opiate craving (P<0.001 for both comparisons with placebo). Rates of adverse events were similar in the active-treatment and placebo groups. During the open-label phase, the percentage of urine samples negative for opiates ranged from 35.2 percent to 67.4 percent. Results from the open-label follow-up study indicated that the combined treatment was safe and well tolerated.

Conclusions

Buprenorphine and naloxone in combination and buprenorphine alone are safe and reduce the use of opiates and the craving for opiates among opiate-addicted persons who receive these medications in an office-based setting.

Figures/Media

  1. Table 1. Base-Line Demographic Characteristics of the Subjects in the Double-Blind Trial and of Those Who Constituted the Group in Whom Safety Was Assessed.
    Table 1. Base-Line Demographic Characteristics of the Subjects in the Double-Blind Trial and of Those Who Constituted the Group in Whom Safety Was Assessed.
  2. Figure 1. Mean (±SD) Scores for Opiate Craving and Subjects' and Clinicians' Impression of Overall Status.
    Figure 1. Mean (±SD) Scores for Opiate Craving and Subjects' and Clinicians' Impression of Overall Status.

    For each of the four study weeks, the mean scores for opiate craving in the combined-treatment and buprenorphine groups were significantly lower than those in the placebo group (P<0.001 for both comparisons each week), and the scores for subjects' and clinicians' global impressions were significantly higher than those in the placebo group (P<0.001 for both comparisons each week). Panel A shows opiate-craving scores for subjects for whom data were available at a given time point (range, 79 to 109 subjects). Panel B shows subjects' impression of their own overall status since enrollment in the study for those for whom data were available at a given time point (range, 75 to 108 subjects). Panel C shows clinicians' impression of the subjects' overall status since enrollment for those for whom data were available at a given time point (range, 75 to 108 subjects). In Panels B and C higher scores indicate better perceived status.

    ELE09 Guess FLVNT3 Boots Ankle Black Black qBOTRv
  3. Table 2. Adverse Events Reported by at Least 5 Percent of the Subjects in Any Treatment Group during the Double-Blind Trial.
    Table 2. Adverse Events Reported by at Least 5 Percent of the Subjects in Any Treatment Group during the Double-Blind Trial.
  4. Figure 2. Percentage of Urine Samples Negative for Opiates, Cocaine, or Benzodiazepines among Subjects Who Received Combination Treatment with Buprenorphine and Naloxone.
    Figure 2. Percentage of Urine Samples Negative for Opiates, Cocaine, or Benzodiazepines among Subjects Who Received Combination Treatment with Buprenorphine and Naloxone.

    The data shown for week 4 include results from subjects in the double-blind trial and the open-label study; only the first urine sample collected during week 4 was analyzed for both opiate and nonopiate drugs. The differences between the numbers of samples analyzed for cocaine or benzodiazepines and the number analyzed for opiates at weeks 8, 12, 16, and 28 reflect missing data.

More about

 
 
 
PHYSICIAN JOBS
September 7, 2018
 
 
 
Endocrinology
Rochester, New York
 
 
Endocrinology
Reading, Pennsylvania
 
Endocrinology
Toledo, Ohio
 
Natural Pump Anne Women's Falicia Klein Patent xwXw0H7qRB
  • Original Article
    Chronic Renal Failure after Transplantation of a Nonrenal Organ
    A.O. Ojo and Others
  • Images in Clinical Medicine
    The Harlequin Color Change
    J. Rao and A. Krol
  • Original Article
    Oxygen-Saturation Targets and Outcomes in Extremely Preterm Infants
    L.M. Askie and Others
  • Review Article
    Genomics as a Probe for Disease Biology
    W. Burke
  • Perspective
    Office-Based Practice and Opioid-Use Disorders
    H.W. Clark
  • Editorial
    Welcome to the Genomic Era
    A.E. Guttmacher and F.S. Collins
  • Original Article
    Inhibition of Food Intake in Obese Subjects by Peptide YY3–36
    R.L. Batterham and Others
  • Dress Cream Lace Jax Women's Jax Women's 4xqXC6IHww
  • Perspective
    Prescription-Drug Coverage for Medicare Beneficiaries
    J.K. Iglehart
  • Images in Clinical Medicine
    Chondroid Clival Chordoma
    A.M. Stark and H.M. Mehdorn
  • Review Article
    Drug Addiction
    J. Camí and M. Farré
  • Clinical Problem-SolvingT Swing Afibi Short Sleeve Size Casual Pockets Lavender Dresses Women's Loose Plus Shirt CHwqCRz
    Anatomy of a Diagnosis
    H.R. Collard and Others
  • Perspective
    To Eat or Not to Eat — How the Gut Talks to the Brain
    J. Korner and R.L. Leibel
  • Original Article
    Chronic Renal Failure after Transplantation of a Nonrenal Organ
    A.O. Ojo and Others