The Effect of Phentermine and B12 on Weight Loss Among Obese Patients

NCT ID: NCT01719185

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2013-04-30

Brief Summary

This is a pilot study designed to test the hypothesis that the combination of phentermine and B12 will result in significantly greater weight loss among obese patients compared to phentermine alone.

Detailed Description

This pilot study is a double blind, randomized controlled trial designed to determine the significance of the combination therapy of phentermine and B12 injections among the obese population. The study population will be recruited from the ECU Physicians Internal Medicine clinic. Physicians will select patients meeting inclusion and exclusion criteria from their clinic to be approached for recruitment. Approximately 30 patients will be recruited and blindly randomized to either the treatment group (phentermine and B12 in combination) or the control group (phentermine alone). Patients will be randomized by means of block randomization in a 1:1 ratio. Neither patients nor study team members will be aware of group assignments through the entire duration of the study. Once randomized, both groups will begin taking 37.5 mg/day orally of phentermine as well as receive weekly intramuscular injections of either 1000 mg B12 or Saline depending on their group assignment. The study will consist of approximately 15 visits over the course of 3 months.

Conditions

Obesity; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Phentermine and B12

Those in the experimental group will take 37.5 mg of phentermine daily as well as receive 1000 mg intramuscular injections of B12 weekly.

Group Type: EXPERIMENTAL

Phentermine and B12

Intervention Type: DRUG

Phentermine

Those in the control group will take phentermine 37.5 mg daily as well as receive 1000 mg intramuscular injections of saline weekly.

Group Type: ACTIVE_COMPARATOR

Phentermine

Intervention Type: DRUG

Interventions

Phentermine and B12

Intervention Type: DRUG

Phentermine

Intervention Type: DRUG

Other Intervention Names

Adipex-P, Cyanocobalamin; Adipex- P

Eligibility Criteria

Inclusion Criteria

• Are over the age of 18
• Have a BMI between 30 and 40
• Have a controlled blood pressure
• Do not have a B12 deficiency
• Are willing to take birth control (if female and not sterile or through menopause)
• Are English speaking

Individuals should not participate in if any of the following apply to them:

• Are not over the age of 18
• Do not have a BMI between 30 and 40
• Do not have a controlled blood pressure
• Have a B12 deficiency
• Females who are pregnant, trying to get pregnant, or not willing to use a method of birth control to ensure they do not become pregnant
• Individuals who do not speak English
• Individuals currently taking Adderall, Ritalin, or any other stimulant medication
• Individuals who have taken phentermine more than once in the past, or within 3 months of study initiation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Michael Lang

OTHER

Sponsor Role: lead

Responsible Party

Dr. Michael Lang

Michael Lang, MD, Internal Medicine, Psychiatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael C Lang, MD

Role: PRINCIPAL_INVESTIGATOR

ECU Physicians General Internal Medicine, Psychiatry

James Powell, MD

Role: STUDY_CHAIR

ECU Physicians General Internal Medicine

Locations

Brody Outpatient of Brody Medical Sciences Module D

Greenville, North Carolina, United States

Countries

United States

Other Identifiers

12-001323

Identifier Type: -

Identifier Source: org_study_id