Author Contributions: Dr Garbutt had full access
to all of the data in the study and takes responsibility for the integrity
of the data and the accuracy of the data analysis.
Study concept and design: Kranzler, Silverman,
Loewy, O’Malley, Ehrich.
Acquisition of data: Garbutt, Kranzler, O’Malley,
Analysis and interpretation of data: Garbutt,
Kranzler, Gastfriend, Pettinati, Silverman, Loewy, O’Malley Silverman,
Drafting of the manuscript: Garbutt, Kranzler,
O’Malley, Gastfriend, Pettinati, Silverman, Loewy, Ehrich.
Critical revision of the manuscript for important
intellectual content: Garbutt, Kranzler, O’Malley, Gastfriend,
Pettinati, Silverman, Loewy, Ehrich.
Statistical analysis: Loewy, Ehrich.
Obtained funding: Silverman, Ehrich.
Administrative, technical, or material support:
Study supervision: Garbutt, Kranzler, O’Malley,
Financial Disclosures: Dr Garbutt has served
on the advisory board and received research support from Bristol-Meyers Squibb
and received research support from Alkermes and Oy ContrAl Pharma and has
served on the advisory board and speakers bureau for Forest Laboratories and
has been on the speakers bureau for Wyeth-Ayerst. Dr Kranzler has served as
a consultant for and has research support from Drug Abuse Sciences and Alkermes,
Forest Laboratories, Ortho-McNeil Pharmaceuticals, and Bristol-Myers Squibb.
Dr O’Malley has research support from Alkermes, Forest Laboratories,
Pfizer, Ortho-McNeil, DuPont, Lipha, and Bristol-Myers Squibb and has served
as a consultant for Alkermes, Forest Laboratories, Johnson & Johnson,
Pfizer, and Ortho-McNeil. Dr Gastfriend has served as a consultant for and
on the advisory board and has received research support from and is now employed
at Alkermes. Dr Pettinati has received research support from Alkermes, AstraZeneca,
Bristol-Myers Squibb, Oy ContrAl Pharma, Drug Abuse Sciences, Eli Lilly, Lipha-Merck-KGaA,
Ortho-McNeil, and Pfizer; has served as a consultant for Alkermes, AstraZeneca,
Axis-Shield, Oy ContrAl Pharma, and Titan; and has participated in CME speakers
programs for Forest Laboratories. Drs Silverman, Loewy, and Ehrich are employed
Funding/Support: The preparation of the manuscript
was supported in part by grants K24-AA13736 (Dr Kranzler) and K24-DA00427
(Dr Gastfriend) from the National Institutes of Health. The development of
Vivitrex was supported by a Small Business Innovation Research award, N43AA01002
from the National Institute on Alcohol Abuse and Alcoholism to Alkermes Inc.
This study was funded, conducted, and designed by Alkermes with suggestions
from the investigators.
Role of the Sponsor: Data were collected and
monitored by Alkermes and Pharmaceutical Product Development Inc, a contract
research organization. Data were managed and analyzed by Alkermes clinical
and regulatory personnel and were interpreted by authors on the study with
input from Alkermes clinical and statistical staff. The majority of the first
draft was prepared by the lead author. The draft was reviewed by all authors
over 2 meetings and at least 6 teleconferences, at which time the selection
of data and their interpretation were determined by consensus.
Independent Statistical Review: We thank L.
J. Wei, PhD, professor of biostatistics at Harvard School of Public Health,
for performing an independent review of the data analysis.
Vivitrex Study Group/Principal Investigators: Robert
Anthenelli, MD, Cincinnati, Ohio; Louise Beckett, MD, Oklahoma City, Okla;
Michael Bohn, MD, Middleton, Wis; Paul Casadonte, MD, New York, NY; Domenic
Ciraulo, MD, Boston, Mass; James Garbutt, MD, Chapel Hill, NC; David Gastfriend,
MD, Boston, Mass; Lawrence Ginsberg, MD, Houston, Tex; Hisham Hafez, MD, Nashua,
NH; Bankole Johnson, MD, San Antonio, Tex; Philip Kanof, MD, PhD, Tucson,
Ariz; Henry Kranzler, MD, Farmington, Conn; Sandra Lapham, MD, Albuquerque,
NM; Peter Martin, MD, Nashville, Tenn; Barbara Mason, PhD, Miami, Fla; Mary
McCaul, PhD, Baltimore, Md; Denis Mee-Lee, MD, Honolulu, Hawaii; Stephanie
O’Malley, PhD, New Haven, Conn; Helen Pettinati, PhD, Philadelphia,
Pa; Robert Riesenberg, Atlanta, Ga; Ihsan Salloum, MD, Pittsburgh, Pa; Jeffery
Wilkins, MD, Los Angeles, Calif; Mark Willenbring, MD, Minneapolis, Minn;
Allen Zweben, PhD, Milwaukee, Wis.
Acknowledgment: We thank the staff at Alkermes
for their work in the implementation and biostatistical analysis of this study,
especially: Chester Osborn, MD, Kathleen Ford, Anne Giovanoni, Ari Illeperuma,
Song Liou, and Erin Lake, PhD. Michael Fried, MD, and Patrick O’Connor,
MD, provided helpful comments on the manuscript.